{"product_id":"us-fda-premarket-submission-regulatory-strategy","title":"U.S. FDA Premarket Submission \u0026 Regulatory Strategy","description":"\u003cstyle data-eximio-product-css=\"blue-v6-original-layout-refined\"\u003e .eximio-product-description{ --eximio-blue:#1f5fbf;--eximio-blue-dark:#123e73;--eximio-blue-soft:#f4f8fd; --eximio-text:#334155;--eximio-overview-text:#365777;--eximio-muted:#64748b; --eximio-line:#dbe5f1;--eximio-surface:#f8fafc; width:100%;max-width:none;margin:0;color:var(--eximio-text);font-size:16px;line-height:1.72; -webkit-font-smoothing:antialiased; } .eximio-product-description,.eximio-product-description *{box-sizing:border-box} .eximio-product-description .eximio-product-section{margin:0;padding:25px 0;border:0;background:transparent} .eximio-product-description .eximio-product-section:first-child{padding-top:0} .eximio-product-description .eximio-product-overview{padding-bottom:24px} .eximio-product-description .eximio-product-heading{ display:block;margin:0 0 17px;padding:0 0 10px;color:var(--eximio-blue-dark); border:0;border-bottom:1px solid var(--eximio-line);font-size:clamp(19px,1.7vw,22px); font-weight:650;line-height:1.35;letter-spacing:-.01em } .eximio-product-description p{margin:0 0 13px;color:var(--eximio-text)} .eximio-product-description p:last-child{margin-bottom:0} .eximio-product-description .eximio-product-overview\u003ep{ max-width:920px;color:var(--eximio-overview-text);font-size:17px;line-height:1.82 } .eximio-product-description strong{color:var(--eximio-blue-dark);font-weight:650} .eximio-product-description .eximio-product-table{ width:100%;max-width:100%;margin:16px 0 4px;border:1px solid var(--eximio-line); border-radius:8px;border-collapse:separate;border-spacing:0;background:#fff;table-layout:fixed } .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{ padding:12px 14px;border-right:1px solid var(--eximio-line);border-bottom:1px solid var(--eximio-line); vertical-align:top;text-align:left;font-size:14px;line-height:1.55;overflow-wrap:anywhere } .eximio-product-description .eximio-product-table th{color:var(--eximio-blue-dark);font-weight:650;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-product-table tbody tr:nth-child(even) td{background:var(--eximio-surface)} .eximio-product-description .eximio-product-table tr:last-child\u003e*{border-bottom:0} .eximio-product-description .eximio-product-table tr\u003e*:last-child{border-right:0} .eximio-product-description .eximio-process-intro{max-width:920px;color:var(--eximio-muted)} .eximio-product-description .eximio-route-flow{ margin:20px 0 28px;padding:18px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-route-title{ margin:0 0 6px;color:var(--eximio-blue-dark);font-size:18px;font-weight:650;line-height:1.35 } .eximio-product-description .eximio-route-meta{margin:0 0 15px;color:var(--eximio-muted);font-size:13px} .eximio-product-description .eximio-process{ display:flex;align-items:stretch;gap:8px;overflow-x:auto;padding:2px 0 8px;-webkit-overflow-scrolling:touch } .eximio-product-description .eximio-process-step{ flex:1 0 150px;min-width:150px;padding:13px 12px;border:1px solid #c9daf0;border-radius:9px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;line-height:1.45; display:flex;align-items:center;justify-content:center;text-align:center;font-weight:600 } .eximio-product-description .eximio-process-arrow{ flex:0 0 20px;display:flex;align-items:center;justify-content:center;color:var(--eximio-blue); font-size:20px;font-weight:700 } .eximio-product-description .eximio-note{ margin-top:14px;padding:12px 14px;border-left:3px solid var(--eximio-blue); background:var(--eximio-surface);color:var(--eximio-muted);font-size:13px;line-height:1.55 } @media(max-width:749px){ .eximio-product-description{font-size:15px;line-height:1.68} .eximio-product-description .eximio-product-section{padding:21px 0} .eximio-product-description .eximio-product-heading{margin-bottom:13px;padding-bottom:8px;font-size:18px} .eximio-product-description .eximio-product-overview\u003ep{font-size:16px;line-height:1.76} .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{padding:9px 8px;font-size:12px;line-height:1.4} .eximio-product-description .eximio-route-flow{padding:14px 12px;margin:16px 0 22px} .eximio-product-description .eximio-route-title{font-size:16px} .eximio-product-description .eximio-process{flex-direction:column;overflow:visible;gap:4px} .eximio-product-description .eximio-process-step{flex:0 0 auto;min-width:0;width:100%;min-height:54px} .eximio-product-description .eximio-process-arrow{height:20px;transform:rotate(90deg)} } \/* CSS-only flow switcher: no JavaScript *\/ .eximio-product-description .eximio-flow-switcher{margin:18px 0 6px} .eximio-product-description .eximio-flow-control{ position:absolute!important;width:1px!important;height:1px!important;margin:-1px!important;padding:0!important; overflow:hidden!important;clip:rect(0 0 0 0)!important;white-space:nowrap!important;border:0!important;opacity:0!important } .eximio-product-description .eximio-flow-tab-nav{ display:flex;gap:8px;overflow-x:auto;padding:2px 1px 10px;-webkit-overflow-scrolling:touch;scrollbar-width:thin } .eximio-product-description .eximio-flow-tab{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-height:42px;padding:9px 14px; border:1px solid var(--eximio-line);border-radius:999px;background:#fff;color:var(--eximio-blue-dark); font-size:13px;font-weight:650;line-height:1.25;cursor:pointer;transition:border-color .18s ease,background .18s ease,color .18s ease } .eximio-product-description .eximio-flow-tab:hover{border-color:#9dbde4;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-flow-panels{margin-top:2px} .eximio-product-description .eximio-flow-panel{ display:none;margin:0;padding:18px;border:1px solid var(--eximio-line);border-radius:12px;background:#fff } .eximio-product-description .eximio-flow-panel.is-single{display:block} .eximio-product-description .eximio-flow-head{ display:flex;align-items:flex-start;justify-content:space-between;gap:18px;margin:0 0 15px;padding:0 0 14px; border-bottom:1px solid var(--eximio-line) } .eximio-product-description .eximio-flow-head .eximio-route-title{margin:2px 0 0} .eximio-product-description .eximio-flow-timing{ flex:0 0 min(340px,46%);padding:10px 12px;border:1px solid #c9daf0;border-radius:9px;background:var(--eximio-blue-soft) } .eximio-product-description .eximio-flow-timing-label{ display:block;margin:0 0 2px;color:var(--eximio-muted);font-size:11px;font-weight:700;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-flow-timing strong{ 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rgba(31,95,191,.08);transform:translateY(-1px) } .eximio-product-description .eximio-reg-kind{ display:inline-flex;margin:0 0 7px;padding:3px 7px;border-radius:999px;background:var(--eximio-blue-soft);color:var(--eximio-blue); font-size:10px;font-weight:750;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-reg-title{display:block;color:var(--eximio-blue-dark);font-size:14px;font-weight:700;line-height:1.35} .eximio-product-description .eximio-reg-scope{display:block;margin-top:5px;color:var(--eximio-muted);font-size:12px;line-height:1.5} .eximio-product-description .eximio-reg-source{display:block;margin-top:8px;color:var(--eximio-blue);font-size:11px;font-weight:650} @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{gap:6px;padding-bottom:8px} .eximio-product-description .eximio-flow-tab{min-height:38px;padding:8px 11px;font-size:12px} .eximio-product-description .eximio-flow-panel{padding:14px 12px} .eximio-product-description .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description .eximio-flow-timing{width:100%;max-width:none;margin-top:10px} .eximio-product-description .eximio-flow-panel .eximio-process-step{padding:30px 11px 12px} .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } .eximio-product-description #eximio-us-fda-premarket-submission-regulatory-strategy-1:checked ~ .eximio-flow-tab-nav label[for=\"eximio-us-fda-premarket-submission-regulatory-strategy-1\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-us-fda-premarket-submission-regulatory-strategy-1:checked ~ .eximio-flow-panels .eximio-flow-panel-1{display:block} .eximio-product-description #eximio-us-fda-premarket-submission-regulatory-strategy-2:checked ~ .eximio-flow-tab-nav label[for=\"eximio-us-fda-premarket-submission-regulatory-strategy-2\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-us-fda-premarket-submission-regulatory-strategy-2:checked ~ .eximio-flow-panels .eximio-flow-panel-2{display:block} .eximio-product-description #eximio-us-fda-premarket-submission-regulatory-strategy-3:checked ~ .eximio-flow-tab-nav label[for=\"eximio-us-fda-premarket-submission-regulatory-strategy-3\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-us-fda-premarket-submission-regulatory-strategy-3:checked ~ .eximio-flow-panels .eximio-flow-panel-3{display:block} .eximio-product-description #eximio-us-fda-premarket-submission-regulatory-strategy-4:checked ~ .eximio-flow-tab-nav label[for=\"eximio-us-fda-premarket-submission-regulatory-strategy-4\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-us-fda-premarket-submission-regulatory-strategy-4:checked ~ .eximio-flow-panels .eximio-flow-panel-4{display:block} .eximio-product-description #eximio-us-fda-premarket-submission-regulatory-strategy-5:checked ~ .eximio-flow-tab-nav label[for=\"eximio-us-fda-premarket-submission-regulatory-strategy-5\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-us-fda-premarket-submission-regulatory-strategy-5:checked ~ .eximio-flow-panels .eximio-flow-panel-5{display:block} \/* Mobile flow timeline v3 *\/ @media(max-width:749px){ .eximio-product-description .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px; overflow:visible;padding:0 0 13px } .eximio-product-description .eximio-flow-tab-nav .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-flow-tab{ width:100%;min-height:44px;padding:8px 9px;border-radius:8px; white-space:normal;text-align:center;font-size:12px;line-height:1.3 } .eximio-product-description .eximio-flow-panels{margin-top:0} .eximio-product-description .eximio-flow-panel{ padding:0;border:0;border-radius:0;background:transparent } .eximio-product-description .eximio-flow-head{ display:block;margin:0 0 14px;padding:13px 12px; border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-flow-head .eximio-route-title{ margin:0;color:var(--eximio-blue-dark);font-size:16px } .eximio-product-description .eximio-flow-timing{ width:100%;max-width:none;margin-top:10px;padding:9px 10px;border-radius:8px } .eximio-product-description .eximio-flow-timing strong{font-size:14px} .eximio-product-description .eximio-flow-panel .eximio-process{ position:relative;display:block;overflow:visible;margin:0;padding:0 0 0 34px } .eximio-product-description .eximio-flow-panel .eximio-process:before{ content:\"\";position:absolute;left:11px;top:17px;bottom:17px;width:2px; border-radius:2px;background:#c9daf0 } .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;display:block;width:100%;min-width:0;min-height:0; margin:0 0 11px;padding:12px 12px 12px 13px; border:1px solid #c9daf0;border-radius:9px;background:#fff; text-align:left;color:var(--eximio-blue-dark);font-size:13px;line-height:1.45 } .eximio-product-description .eximio-flow-panel .eximio-process-step:last-of-type{margin-bottom:0} .eximio-product-description .eximio-flow-panel .eximio-process-arrow{display:none} .eximio-product-description .eximio-step-number{ top:11px;left:-34px;min-width:24px;width:24px;height:24px;padding:0; border:2px solid #fff;border-radius:50%;background:var(--eximio-blue);color:#fff; font-size:10px;box-shadow:0 0 0 1px #b9cfea } .eximio-product-description .eximio-step-copy{display:block;font-weight:600} .eximio-product-description .eximio-step-time{ margin-top:7px;padding:4px 7px;border-radius:6px;font-size:10px } .eximio-product-description .eximio-flow-note{margin:11px 0 0;padding-left:34px} .eximio-product-description .eximio-timing-key{ margin-top:13px;padding:10px 11px;font-size:11px } .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* v4 topology-aware flow network: preserves branches, parallel workstreams and merge\/decision points *\/ .eximio-product-description .eximio-network{display:flex;flex-direction:column;align-items:stretch;gap:10px;margin-top:2px} .eximio-product-description .eximio-net-node{ position:relative;max-width:430px;margin:0 auto;padding:12px 14px;border:1px solid #c9daf0;border-radius:10px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;font-weight:650;line-height:1.42;text-align:center } .eximio-product-description .eximio-net-node--start{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff;font-size:14px} .eximio-product-description .eximio-net-node--finish{background:#eaf6ee;border-color:#b8ddc4;color:#245b35} .eximio-product-description .eximio-net-node--alternative{background:#f8fafc;border-style:dashed;color:#475569} .eximio-product-description .eximio-net-node-sub{display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;font-weight:500} .eximio-product-description .eximio-net-time{ display:inline-flex;margin-top:7px;padding:3px 8px;border-radius:999px;background:#fff;color:var(--eximio-blue-dark); border:1px solid #c9daf0;font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-net-node--start .eximio-net-time{color:var(--eximio-blue-dark)} .eximio-product-description .eximio-net-arrow{height:22px;display:flex;align-items:center;justify-content:center;color:#76a2d7;font-size:18px;font-weight:700;line-height:1} .eximio-product-description .eximio-net-arrow--major{height:26px;font-size:21px} .eximio-product-description .eximio-net-seq{display:flex;flex-direction:column;align-items:stretch} .eximio-product-description .eximio-net-seq\u003e.eximio-net-node{width:min(100%,430px)} .eximio-product-description .eximio-net-branch-group{ position:relative;margin:4px 0 8px;padding:16px 14px 14px;border:1px solid var(--eximio-line);border-radius:12px;background:#fbfdff } .eximio-product-description .eximio-net-group-label{ display:inline-flex;position:relative;margin:-29px 0 12px 4px;padding:4px 9px;border:1px solid #c9daf0;border-radius:999px; background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;letter-spacing:.025em;line-height:1.25 } .eximio-product-description .eximio-net-branches{ display:grid;grid-template-columns:repeat(var(--eximio-branch-count),minmax(0,1fr));gap:12px;align-items:stretch } .eximio-product-description .eximio-net-branch{ min-width:0;padding:11px;border:1px solid #d6e2f1;border-radius:10px;background:#fff } .eximio-product-description .eximio-net-branch-head{display:flex;align-items:flex-start;gap:8px;margin:0 0 10px;padding-bottom:8px;border-bottom:1px solid #e6edf6} .eximio-product-description .eximio-net-branch-index{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-width:24px;height:20px;padding:0 5px;border-radius:999px; background:#e8f1fc;color:var(--eximio-blue);font-size:9px;font-weight:800;line-height:1 } .eximio-product-description .eximio-net-branch-title{color:var(--eximio-blue-dark);font-size:12px;font-weight:750;line-height:1.35} .eximio-product-description .eximio-net-branch-note{margin:-3px 0 9px;color:var(--eximio-muted);font-size:10px;line-height:1.4} .eximio-product-description .eximio-net-branch .eximio-net-node{width:100%;max-width:none;padding:10px 8px;font-size:11px} .eximio-product-description .eximio-net-branch .eximio-net-arrow{height:17px;font-size:14px} .eximio-product-description .eximio-net-junction{ width:min(100%,560px);margin:1px auto;padding:9px 12px;border:1px dashed #9dbde4;border-radius:9px;background:#f7fbff; color:var(--eximio-blue-dark);font-size:11px;font-weight:700;line-height:1.4;text-align:center } .eximio-product-description .eximio-net-junction--decision{border-style:solid;background:#eef5fd} .eximio-product-description .eximio-net-branch-group--decision .eximio-net-group-label{color:#475569;border-color:#cbd5e1} .eximio-product-description .eximio-net-branch-group--outputs{background:#f8fbff} @media(max-width:980px) and (min-width:750px){ .eximio-product-description .eximio-net-branches{grid-template-columns:repeat(2,minmax(0,1fr))} } @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px;overflow:visible;padding:2px 0 9px } .eximio-product-description .eximio-flow-tab{ width:100%;min-width:0;min-height:42px;padding:8px 7px;border-radius:8px;white-space:normal;text-align:center;font-size:11px } .eximio-product-description .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-net-node{max-width:none;width:100%;padding:11px 10px;font-size:12px;text-align:left} .eximio-product-description .eximio-net-node--start{text-align:center} .eximio-product-description .eximio-net-branches{grid-template-columns:1fr;gap:9px} .eximio-product-description .eximio-net-branch-group{padding:15px 9px 10px;margin-top:8px} .eximio-product-description .eximio-net-group-label{ margin:-28px 0 10px 2px;max-width:calc(100% - 4px);white-space:normal;border-radius:7px;font-size:9px } .eximio-product-description .eximio-net-branch{padding:10px 9px} .eximio-product-description .eximio-net-branch-head{margin-bottom:8px} .eximio-product-description .eximio-net-branch-title{font-size:12px} .eximio-product-description .eximio-net-branch .eximio-net-node{ padding:9px 10px;border-left:3px solid #9dbde4;border-radius:7px;text-align:left;font-size:11px } .eximio-product-description .eximio-net-branch .eximio-net-node--finish{border-left-color:#8bc59c} .eximio-product-description .eximio-net-arrow{height:18px} .eximio-product-description .eximio-net-junction{width:100%;font-size:10px;text-align:left} } \/* v5 source-layout reconstruction: preserves the original diagram geometry while applying EXIMIO visual language *\/ .eximio-product-description--v6 .eximio-process-intro{max-width:980px} .eximio-product-description--v6 .eximio-flow-tab-nav{display:flex;flex-wrap:wrap;gap:8px;margin:16px 0 18px} .eximio-product-description--v6 .eximio-flow-tab{flex:0 1 auto;min-width:128px;padding:9px 13px;border:1px solid #cbdcf0;border-radius:8px;background:#fff;color:#315a82;font-size:12px;font-weight:650;line-height:1.35;text-align:center;cursor:pointer;transition:.15s ease} .eximio-product-description--v6 .eximio-flow-control{position:absolute!important;opacity:0!important;pointer-events:none!important} .eximio-product-description--v6 .eximio-flow-panel{display:none} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-tab-nav\u003elabel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-tab-nav\u003elabel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-tab-nav\u003elabel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-tab-nav\u003elabel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-tab-nav\u003elabel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-tab-nav\u003elabel:nth-child(6){background:#eaf2fc;border-color:#7fa7d7;color:#123e73;box-shadow:inset 0 0 0 1px #7fa7d7} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(6){display:block} .eximio-product-description--v6 .eximio-flow-panel{padding:18px;border:1px solid #dbe5f1;border-radius:12px;background:#fff} .eximio-product-description--v6 .eximio-flow-head{display:flex;gap:16px;align-items:flex-start;justify-content:space-between;margin-bottom:12px} .eximio-product-description--v6 .eximio-flow-timing{flex:0 0 auto;min-width:180px;padding:9px 11px;border:1px solid #d9e5f3;border-radius:8px;background:#f8fbff;text-align:right} .eximio-product-description--v6 .eximio-flow-timing span,.eximio-product-description--v6 .eximio-flow-timing small{display:block;color:#64748b;font-size:10px;line-height:1.35} .eximio-product-description--v6 .eximio-flow-timing strong{display:block;margin:2px 0;color:#123e73;font-size:13px;line-height:1.35} .eximio-product-description--v6 .eximio-map-scroll{width:100%;overflow-x:auto;overflow-y:hidden;padding:4px 0 8px;-webkit-overflow-scrolling:touch;scrollbar-width:thin} .eximio-product-description--v6 .eximio-map{position:relative;width:100%;aspect-ratio:var(--flow-ratio);min-height:420px;border:1px solid #e2eaf4;border-radius:12px;background:linear-gradient(180deg,#fbfdff 0%,#fff 100%);overflow:hidden} .eximio-product-description--v6 .eximio-map--dense{min-width:760px} .eximio-product-description--v6 .eximio-map-wire{position:absolute;z-index:1;background:#8eb3df;opacity:.88} .eximio-product-description--v6 .eximio-map-wire--v{width:1.5px;transform:translateX(-.75px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.5px;transform:translateY(-.75px)} .eximio-product-description--v6 .eximio-map-node{position:absolute;z-index:3;left:var(--x);top:var(--y);width:var(--nw,18%);transform:translate(-50%,-50%);padding:8px 9px;border:1px solid #bcd2ea;border-radius:10px;background:#f2f7fd;color:#234f78;font-size:11px;font-weight:650;line-height:1.28;text-align:center;box-shadow:0 2px 7px rgba(31,95,191,.06);overflow-wrap:anywhere} .eximio-product-description--v6 .eximio-map-node--start{background:#123e73;border-color:#123e73;color:#fff;font-size:12px} .eximio-product-description--v6 .eximio-map-node--finish{background:#eaf5f8;border-color:#8fc4d0;color:#174e5c} .eximio-product-description--v6 .eximio-map-node--decision{background:#fff;border:1.5px solid #1f5fbf;color:#123e73} .eximio-product-description--v6 .eximio-map-node--alternative{background:#fff;border:1px dashed #7d8ea2;color:#485a6d;font-size:10px} .eximio-product-description--v6 .eximio-map-node-sub{display:block;margin-top:3px;color:inherit;opacity:.72;font-size:9px;font-weight:500} .eximio-product-description--v6 .eximio-map-bracket:before,.eximio-product-description--v6 .eximio-map-bracket:after{content:\"\";position:absolute;right:-1px;width:9px;border-top:1px solid #8095aa} .eximio-product-description--v6 .eximio-map-note{position:absolute;z-index:4;transform:translate(-50%,-50%);padding:3px 7px;border-radius:999px;background:#fff;border:1px solid #d5e2f1;color:#61758b;font-size:9px;font-weight:650;line-height:1.25;white-space:nowrap} @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px} .eximio-product-description--v6 .eximio-flow-tab{min-width:0;padding:8px 7px;font-size:11px} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:10px} .eximio-product-description--v6 .eximio-flow-timing{min-width:0;margin-top:8px;text-align:left} .eximio-product-description--v6 .eximio-flow-panel{padding:10px} .eximio-product-description--v6 .eximio-map{min-height:390px} .eximio-product-description--v6 .eximio-map--dense{min-width:680px;min-height:500px} .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.24} .eximio-product-description--v6 .eximio-map-node--start{font-size:11px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:9px} .eximio-product-description--v6 .eximio-map-note{font-size:8px} } \/* V6 layout refinement: preserve original geometry, improve hierarchy and readability *\/ .eximio-product-description--v6 .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description--v6 .eximio-flow-tab-nav{ gap:5px;padding:5px;margin:0 0 12px;border:1px solid #e1eaf4;border-radius:12px; background:#f7fafe;scrollbar-width:thin } .eximio-product-description--v6 .eximio-flow-tab{ min-height:40px;padding:8px 13px;border-color:transparent;border-radius:8px;background:transparent; font-size:12.5px } .eximio-product-description--v6 .eximio-flow-tab:hover{border-color:#c6d9ef;background:#fff} .eximio-product-description--v6 .eximio-flow-panel{ padding:20px;border-color:#dce7f3;border-radius:14px;box-shadow:0 8px 24px rgba(18,62,115,.045) } .eximio-product-description--v6 .eximio-flow-head{ align-items:center;gap:24px;margin-bottom:18px;padding-bottom:15px } .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{ margin:0;font-size:19px;line-height:1.3 } .eximio-product-description--v6 .eximio-flow-timing{ flex:0 0 min(300px,40%);padding:9px 12px;border-radius:8px;background:#f5f9fe } .eximio-product-description--v6 .eximio-flow-timing span{ color:#64748b;font-size:10px;font-weight:750;letter-spacing:.045em;text-transform:uppercase } .eximio-product-description--v6 .eximio-flow-timing strong{margin-top:1px;font-size:14px} .eximio-product-description--v6 .eximio-flow-timing small{margin-top:2px;font-size:10px} .eximio-product-description--v6 .eximio-map-scroll{ position:relative;width:100%;padding:4px 0 8px;overflow-x:auto;overflow-y:hidden } .eximio-product-description--v6 .eximio-map{ width:100%;max-width:1160px;margin:0 auto;min-height:430px;border-color:#dde8f3;border-radius:14px; background:#fff; overflow:hidden;box-shadow:none } .eximio-product-description--v6 .eximio-map-wire{ background:#9ebbd9;opacity:.82;border-radius:999px } .eximio-product-description--v6 .eximio-map-wire--v{width:1.25px;transform:translateX(-.625px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.25px;transform:translateY(-.625px)} .eximio-product-description--v6 .eximio-map-node{ padding:9px 10px;border-color:#bdd2e8;border-radius:9px;background:#f4f8fd; color:#234f78;font-size:11.5px;line-height:1.32;font-weight:650; box-shadow:0 3px 10px rgba(18,62,115,.055) } .eximio-product-description--v6 .eximio-map-node--start{ padding-top:10px;padding-bottom:10px;background:#123e73;border-color:#123e73;color:#fff; font-size:12px;box-shadow:0 5px 14px rgba(18,62,115,.14) } .eximio-product-description--v6 .eximio-map-node--finish{ background:#edf8fa;border-color:#9ccbd4;color:#164d5a } .eximio-product-description--v6 .eximio-map-node--decision{ background:#fff;border:1.5px solid #3f79c2;color:#123e73;box-shadow:0 4px 12px rgba(31,95,191,.07) } .eximio-product-description--v6 .eximio-map-node--alternative{ background:#fff;border-color:#a7b5c5;color:#526274;font-size:10px;box-shadow:none } .eximio-product-description--v6 .eximio-map-node-sub{ margin-top:3px;font-size:9px;line-height:1.25;opacity:.7 } .eximio-product-description--v6 .eximio-map-note{ padding:3px 6px;border-color:#d4e1ee;background:rgba(255,255,255,.96);color:#60758a; font-size:8.5px;box-shadow:0 2px 6px rgba(18,62,115,.035) } @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:5px;padding:5px;margin-bottom:10px } .eximio-product-description--v6 .eximio-flow-tab{min-height:38px;padding:7px 7px;font-size:11px;line-height:1.2} .eximio-product-description--v6 .eximio-flow-panel{padding:12px 10px;border-radius:12px;box-shadow:none} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{font-size:16px} .eximio-product-description--v6 .eximio-flow-timing{width:100%;max-width:none;margin-top:8px;padding:7px 9px} .eximio-product-description--v6 .eximio-flow-timing strong{font-size:13px} .eximio-product-description--v6 .eximio-map-scroll{ margin:0;padding:24px 0 10px;overscroll-behavior-x:contain;scroll-snap-type:x proximity } .eximio-product-description--v6 .eximio-map{ width:620px;min-width:620px;max-width:none;min-height:430px;margin-left:0;margin-right:0 } .eximio-product-description--v6 .eximio-map--dense{ width:820px;min-width:820px;min-height:510px } .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.25} .eximio-product-description--v6 .eximio-map-node--start{font-size:10.5px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:8.5px} .eximio-product-description--v6 .eximio-map-note{font-size:7.5px} } \u003c\/style\u003e\u003cdiv class=\"eximio-product-description eximio-product-description--v6\"\u003e \u003csection class=\"eximio-product-section eximio-product-overview\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eService Overview\u003c\/h2\u003e \u003cp\u003eEXIMIO provides regulatory support for medical-device manufacturers preparing to enter the U.S. market. The service covers regulatory strategy, FDA interaction planning, technical-document preparation, submission coordination and response support across the main premarket routes represented in the source material.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eProcess Flow \u0026amp; Timing\u003c\/h2\u003e \u003cp class=\"eximio-process-intro\"\u003eSelect a route below to view the workflow and timing.\u003c\/p\u003e \u003cdiv class=\"eximio-flow-switcher\"\u003e \u003cinput checked class=\"eximio-flow-control\" id=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-1\" name=\"eximio-v6-flow-us-fda-premarket-submission-regulatory-strategy\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-2\" name=\"eximio-v6-flow-us-fda-premarket-submission-regulatory-strategy\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-3\" name=\"eximio-v6-flow-us-fda-premarket-submission-regulatory-strategy\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-4\" name=\"eximio-v6-flow-us-fda-premarket-submission-regulatory-strategy\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-5\" name=\"eximio-v6-flow-us-fda-premarket-submission-regulatory-strategy\" type=\"radio\"\u003e\u003cdiv aria-label=\"Service route\" class=\"eximio-flow-tab-nav\" role=\"tablist\"\u003e \u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-1\"\u003ePre-Submission (Q-Sub)\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-2\"\u003e513(g) Request\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-3\"\u003e510(k) Premarket Notification\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-4\"\u003eDe Novo Request\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-5\"\u003ePMA (Modular)\u003c\/label\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panels\"\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003ePre-Submission (Q-Sub)\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eFDA feedback target\u003c\/span\u003e\u003cstrong\u003e~70 calendar days\u003c\/strong\u003e\u003csmall\u003eOfficial authority target\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:1.45\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:6.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:10.00%;top:14.00%;width:40.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:10.00%;top:14.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:30.00%;top:14.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:30.00%;top:14.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:6.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:14.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:14.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:14.00%;width:40.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:90.00%;top:14.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:10.00%;top:24.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:10.00%;top:38.00%;width:40.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:38.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:30.00%;top:24.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:30.00%;top:38.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:24.00%;height:26.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:24.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:38.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:90.00%;top:24.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:38.00%;width:40.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:50.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:68.00%;height:20.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:6%;--nw:22%\"\u003eQ-Sub \/ Pre-Submission\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:10%;--y:24%;--nw:16%\"\u003ePre-Submission Procedure\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:30%;--y:24%;--nw:16%\"\u003eQuestions \/ FDA Feedback\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:24%;--nw:16%\"\u003eStudy Risk Definition\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:24%;--nw:16%\"\u003eInformation Meeting\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:90%;--y:24%;--nw:16%\"\u003eCommunication \/ Follow-up\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:50%;--nw:20%\"\u003eProduct Testing \/ Evidence\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:68%;--nw:21%\"\u003eCompile Submission Package\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:88%;--nw:22%\"\u003eFDA Feedback \/ Recommendations\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003e513(g) Request\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eExpected FDA response window\u003c\/span\u003e\u003cstrong\u003e~60 days\u003c\/strong\u003e\u003csmall\u003eOfficial guidance + source timing\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map\" style=\"--flow-ratio:0.98\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:64.00%;top:6.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:20.00%;top:14.00%;width:44.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:20.00%;top:14.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:64.00%;top:6.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:20.00%;top:23.00%;height:21.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:20.00%;top:44.00%;height:21.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:20.00%;top:65.00%;height:23.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:64.00%;top:24.00%;height:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:64.00%;top:46.00%;height:21.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:64.00%;top:67.00%;height:22.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:64%;--y:6%;--nw:22%\"\u003eFDA 513(g) Request\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:20%;--y:23%;--nw:19%\"\u003eConfirm U.S. Agent\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:20%;--y:44%;--nw:19%\"\u003eApply for D-U-N-S\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:20%;--y:65%;--nw:19%\"\u003ePay Annual Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:20%;--y:88%;--nw:23%\"\u003eEstablishment Registration \u0026amp; Device Listing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:64%;--y:24%;--nw:20%\"\u003eProvide Device Information\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:64%;--y:46%;--nw:20%\"\u003eSubmit 513(g) Request\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:64%;--y:67%;--nw:22%\"\u003eFDA Review \/ Supplemental Information\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:64%;--y:89%;--nw:20%\"\u003eFDA Written Response\u003c\/div\u003e \u003cdiv class=\"eximio-map-note\" style=\"left:38%;top:13%\"\u003eEnterprise registration ~90 days\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003e510(k) Premarket Notification\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eFDA review goal\u003c\/span\u003e\u003cstrong\u003e90 FDA days\u003c\/strong\u003e\u003csmall\u003eOfficial authority target\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map\" style=\"--flow-ratio:0.76\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:62.00%;top:5.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:14.00%;top:11.00%;width:48.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:11.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:62.00%;top:5.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:62.00%;top:12.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:82.00%;top:12.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:62.00%;top:5.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:60.00%;top:15.00%;width:2.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:15.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:82.00%;top:18.00%;height:4.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:60.00%;top:22.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:22.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:18.00%;height:24.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:42.00%;height:23.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:65.00%;height:27.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:25.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:39.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:52.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:65.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:77.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:87.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:94.00%;height:2.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:14.00%;top:94.00%;width:46.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:92.00%;height:2.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:62%;--y:5%;--nw:22%\"\u003e510(k) Premarket Notification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:14%;--y:18%;--nw:18%\"\u003eConfirm U.S. Agent\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:14%;--y:42%;--nw:18%\"\u003eApply for D-U-N-S\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:14%;--y:65%;--nw:18%\"\u003ePay Annual Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:14%;--y:92%;--nw:24%\"\u003eEstablishment Registration \u0026amp; Device Listing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:82%;--y:18%;--nw:19%\"\u003eApplicant \/ Company Information\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:25%;--nw:22%\"\u003ePredicate \/ Substantial Equivalence Strategy\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:39%;--nw:21%\"\u003eApplicable Standards \u0026amp; Test Items\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:52%;--nw:18%\"\u003eProduct Testing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:65%;--nw:19%\"\u003eTechnical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:77%;--nw:20%\"\u003eFDA First Review \/ Supplement\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:87%;--nw:20%\"\u003eFDA Second Review \/ Supplement\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:60%;--y:96%;--nw:20%\"\u003eFormal 510(k) \/ K Number\u003c\/div\u003e \u003cdiv class=\"eximio-map-note\" style=\"left:36%;top:10%\"\u003eEstablishment registration ~90 days\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eDe Novo Request\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eFDA review goal\u003c\/span\u003e\u003cstrong\u003e150 review days\u003c\/strong\u003e\u003csmall\u003eOfficial authority target\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map\" style=\"--flow-ratio:0.7\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:5.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:14.00%;top:12.00%;width:46.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:5.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:20.00%;height:25.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:45.00%;height:24.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:69.00%;height:23.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:18.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:31.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:43.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:55.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:67.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:36.00%;top:78.00%;width:24.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:60.00%;top:78.00%;width:25.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:78.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:89.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:60%;--y:5%;--nw:21%\"\u003eFDA De Novo Request\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:14%;--y:20%;--nw:18%\"\u003eConfirm U.S. Agent\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:14%;--y:45%;--nw:18%\"\u003eApply for D-U-N-S\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:14%;--y:69%;--nw:18%\"\u003ePay Annual Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:14%;--y:92%;--nw:24%\"\u003eEstablishment Registration \u0026amp; Device Listing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:18%;--nw:20%\"\u003eOptional Pre-Submission\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:31%;--nw:18%\"\u003eFDA Feedback\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:43%;--nw:18%\"\u003eProduct Testing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:55%;--nw:19%\"\u003eTechnical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:67%;--nw:20%\"\u003eSubmit De Novo Request\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--decision\" style=\"--x:60%;--y:78%;--nw:22%\"\u003eFDA Classification \/ Pathway Decision\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--alternative\" style=\"--x:36%;--y:78%;--nw:18%\"\u003eAlternative: PMA Pathway\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--alternative\" style=\"--x:85%;--y:78%;--nw:18%\"\u003eAlternative: 510(k) Pathway\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:89%;--nw:22%\"\u003eFDA Substantive Review \/ Supplement\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:60%;--y:98%;--nw:19%\"\u003eDe Novo Granted\u003c\/div\u003e \u003cdiv class=\"eximio-map-note\" style=\"left:35%;top:10%\"\u003eEstablishment registration ~90 days\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003ePMA (Modular)\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eFDA PMA review goal\u003c\/span\u003e\u003cstrong\u003e180 FDA days\u003c\/strong\u003e\u003csmall\u003eOfficial authority target\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:1.35\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:55.00%;top:5.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:9.00%;top:12.00%;width:46.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:9.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:32.00%;top:12.00%;width:23.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:32.00%;top:12.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:55.00%;top:5.00%;height:7.50%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:54.00%;top:12.50%;width:1.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:54.00%;top:12.50%;height:7.50%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:55.00%;top:12.00%;width:23.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:78.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:78.00%;top:20.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:78.00%;top:26.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:90.00%;top:26.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:54.00%;top:20.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:9.00%;top:20.00%;height:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:9.00%;top:40.00%;height:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:9.00%;top:62.00%;height:30.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:32.00%;top:21.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:27.00%;top:38.00%;width:5.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:27.00%;top:38.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:54.00%;top:33.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:27.00%;top:42.00%;width:27.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:27.00%;top:42.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:90.00%;top:32.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:27.00%;top:42.00%;width:63.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:27.00%;top:52.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:39.00%;top:52.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:51.00%;top:52.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:63.00%;top:52.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:75.00%;top:52.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:87.00%;top:52.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:63.00%;top:61.00%;width:24.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:61.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:68.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:81.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:93.00%;height:1.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:9.00%;top:93.00%;width:54.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:9.00%;top:92.00%;height:1.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:55%;--y:5%;--nw:20%\"\u003ePMA Registration (Modular)\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:9%;--y:20%;--nw:16%\"\u003eConfirm U.S. Agent\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:9%;--y:40%;--nw:16%\"\u003eApply for D-U-N-S\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:9%;--y:62%;--nw:16%\"\u003ePay Annual Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:9%;--y:92%;--nw:22%\"\u003eEstablishment Registration \u0026amp; Device Listing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:32%;--y:21%;--nw:18%\"\u003eQMS \/ QSR Readiness\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:54%;--y:20%;--nw:17%\"\u003ePMA Shell\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:54%;--y:33%;--nw:18%\"\u003eFDA Alignment \/ Confirmation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:78%;--y:20%;--nw:16%\"\u003eProduct Testing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:90%;--y:32%;--nw:16%\"\u003eClinical Testing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:27%;--y:52%;--nw:13%\"\u003eModule 1\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:39%;--y:52%;--nw:13%\"\u003eFDA Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:51%;--y:52%;--nw:13%\"\u003eModule 2\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:63%;--y:52%;--nw:13%\"\u003eFDA Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:75%;--y:52%;--nw:13%\"\u003eModule 3\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:87%;--y:52%;--nw:13%\"\u003eFDA Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:63%;--y:68%;--nw:16%\"\u003eFinal Module\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:63%;--y:81%;--nw:20%\"\u003eFDA Final Review \/ Supplement\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:63%;--y:94%;--nw:18%\"\u003ePMA Approval\u003c\/div\u003e \u003cdiv class=\"eximio-map-note\" style=\"left:27%;top:10%\"\u003eEstablishment registration ~90 days\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eRegulatory Basis \u0026amp; Official References\u003c\/h2\u003e \u003cp\u003eLegal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.\u003c\/p\u003e \u003cdiv class=\"eximio-regulatory-grid\"\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-807\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003e21 CFR Part 807\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003ePremarket notification (510(k)) and related registration\/listing provisions.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-860\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003e21 CFR Part 860\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eMedical device classification procedures, including De Novo classification.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-814\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003e21 CFR Part 814\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003ePremarket Approval (PMA) requirements and procedures.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/uscode.house.gov\/view.xhtml?req=granuleid:USC-prelim-title21-section360c\u0026amp;num=0\u0026amp;edition=prelim\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eStatute\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eFD\u0026amp;C Act §513 \/ 21 U.S.C. §360c\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eDevice classification framework and statutory basis for §513(g) requests.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/requests-feedback-and-meetings-medical-device-submissions-q-submission-program\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eFDA Q-Submission Program — May 2025\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent FDA guidance for Pre-Submissions, feedback and meetings.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eFDA §513(g) Requests — August 2024\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent FDA procedure for §513(g) classification \/ requirements inquiries.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eRelated Regulatory Support\u003c\/h2\u003e \u003cp\u003eFDA medical device listing, UDI support, U.S. agent coordination and post-submission regulatory support can be arranged as related services.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eEXIMIO Support\u003c\/h2\u003e \u003cp\u003eContact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.\u003c\/p\u003e \u003c\/section\u003e \u003c\/div\u003e","brand":"EXIMIO BIOTEC","offers":[{"title":"Pre-Submission (Q-Sub)","offer_id":47472020095132,"sku":"REG-FDA-PRESUB","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"513(g) Request","offer_id":47472020127900,"sku":"REG-FDA-513G","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"510(k) Premarket Notification","offer_id":47472020160668,"sku":"REG-FDA-510K","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"De Novo Request","offer_id":47472020193436,"sku":"REG-FDA-DENOVO","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"PMA (Modular)","offer_id":47472020226204,"sku":"REG-FDA-PMA-MOD","price":0.0,"currency_code":"CNY","in_stock":true}],"url":"https:\/\/exmbio.com\/products\/us-fda-premarket-submission-regulatory-strategy","provider":"EXIMIO BIOTEC","version":"1.0","type":"link"}