U.S. FDA Premarket Submission & Regulatory Strategy
Regulatory support for U.S. FDA pathways including Pre-Submission, 513(g), 510(k), De Novo and Modular PMA. EXIMIO can support pathway planning, dossier preparation, submission coordination and review follow-up.
Choose an option
Service Overview
EXIMIO 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.
Process Flow & Timing
Select a route below to view the workflow and timing.
Pre-Submission (Q-Sub)
FDA feedback target~70 calendar daysOfficial authority target
Q-Sub / Pre-Submission
Pre-Submission Procedure
Questions / FDA Feedback
Study Risk Definition
Information Meeting
Communication / Follow-up
Product Testing / Evidence
Compile Submission Package
FDA Feedback / Recommendations
513(g) Request
Expected FDA response window~60 daysOfficial guidance + source timing
FDA 513(g) Request
Confirm U.S. Agent
Apply for D-U-N-S
Pay Annual Fee
Establishment Registration & Device Listing
Provide Device Information
Submit 513(g) Request
FDA Review / Supplemental Information
FDA Written Response
Enterprise registration ~90 days
510(k) Premarket Notification
FDA review goal90 FDA daysOfficial authority target
510(k) Premarket Notification
Confirm U.S. Agent
Apply for D-U-N-S
Pay Annual Fee
Establishment Registration & Device Listing
Applicant / Company Information
Predicate / Substantial Equivalence Strategy
Applicable Standards & Test Items
Product Testing
Technical Documentation
FDA First Review / Supplement
FDA Second Review / Supplement
Formal 510(k) / K Number
Establishment registration ~90 days
De Novo Request
FDA review goal150 review daysOfficial authority target
FDA De Novo Request
Confirm U.S. Agent
Apply for D-U-N-S
Pay Annual Fee
Establishment Registration & Device Listing
Optional Pre-Submission
FDA Feedback
Product Testing
Technical Documentation
Submit De Novo Request
FDA Classification / Pathway Decision
Alternative: PMA Pathway
Alternative: 510(k) Pathway
FDA Substantive Review / Supplement
De Novo Granted
Establishment registration ~90 days
PMA (Modular)
FDA PMA review goal180 FDA daysOfficial authority target
PMA Registration (Modular)
Confirm U.S. Agent
Apply for D-U-N-S
Pay Annual Fee
Establishment Registration & Device Listing
QMS / QSR Readiness
PMA Shell
FDA Alignment / Confirmation
Product Testing
Clinical Testing
Module 1
FDA Review
Module 2
FDA Review
Module 3
FDA Review
Final Module
FDA Final Review / Supplement
PMA Approval
Establishment registration ~90 days
Regulatory Basis & Official References
Legal 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.
Law21 CFR Part 807Premarket notification (510(k)) and related registration/listing provisions.Open official source ↗Law21 CFR Part 860Medical device classification procedures, including De Novo classification.Open official source ↗Law21 CFR Part 814Premarket Approval (PMA) requirements and procedures.Open official source ↗StatuteFD&C Act §513 / 21 U.S.C. §360cDevice classification framework and statutory basis for §513(g) requests.Open official source ↗Official GuidanceFDA Q-Submission Program — May 2025Current FDA guidance for Pre-Submissions, feedback and meetings.Open official source ↗Official GuidanceFDA §513(g) Requests — August 2024Current FDA procedure for §513(g) classification / requirements inquiries.Open official source ↗
Related Regulatory Support
FDA medical device listing, UDI support, U.S. agent coordination and post-submission regulatory support can be arranged as related services.
EXIMIO Support
Contact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.