United States Medical Device Registration
Food and Drug Administration (FDA) approval timelines and requirements
United States Medical Device Registration Overview
United States medical device registration through FDA typically takes 6-12 months for 510(k) devices. The official FDA target is 3 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.United States uses a 3-class with pathways (I, II, III) risk-based classification system. Foreign manufacturers must appoint a US Agent to register devices in United States. FDA accepts MDSAP certification, which substitutes routine fda inspections. Registration is valid for Annual registration renewal.
United States uses a 3-class with pathways (I, II, III) risk-based classification system.
510(k)
Premarket Notification
Accelerated with: Prior 510(k) as predicate, Pre-Sub meeting
• MDUFA V goal: 90 FDA days
• Average actual: 160-176 calendar days
De Novo
De Novo Classification
• For novel devices without predicate
• Only 23.8% reviewed within 150 days
PMA
Premarket Approval
Accelerated with: Breakthrough Device Designation
• Includes clinical trial development
• FDA review: 9-12 months after trials
Breakthrough Device Designation
Priority review for innovative devices addressing unmet needs
Pre-Submission (Q-Sub)
FDA meeting to align requirements before submission
Existing approvals from other regulatory authorities can accelerate your United States registration.
- US Agent (for foreign manufacturers)
- Establishment Registration
- Device Listing
- QSR/21 CFR 820 compliance
- eSTAR submission (mandatory Oct 2025)
Annual registration renewal
Substitutes routine FDA inspections
United States Medical Device Registration Process
Step-by-step FDA registration process. Total estimated timeline: 6-12 months.
Step 1: Device Classification
2-4 weeksDetermine FDA device class (I, II, or III) and identify predicate device for 510(k) submissions.
Step 2: Pre-Submission Meeting
2-3 monthsOptional Q-Sub meeting with FDA to discuss testing strategy and submission requirements.
Step 3: Testing & Documentation
3-6 monthsComplete biocompatibility, EMC, performance testing. Prepare technical file and 510(k) summary.
Step 4: 510(k) Submission
1 daySubmit 510(k) application to FDA via eCopy or eSTAR. Pay user fee (currently $22,381 for small business).
Step 5: FDA Review
90-180 daysFDA conducts substantive review. Average 160-176 calendar days. May issue Additional Information requests.
Step 6: 510(k) Clearance
1 dayFDA issues clearance letter (SE = Substantially Equivalent). Device can be marketed in the USA.
Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.