United States medical device registration timeline

Source-linked clocks

Food and Drug Administration (FDA) review clocks and end-to-end planning ranges, using the 3-class with pathways (I, II, III) classification system.

3 pathways3 of 3 clocks verifiedvalidity Annual registration renewalMDSAP acceptedreviewed 2026-08-25fda.gov

Class / pathway	Review clock	Planning total	With prior approval	Provenance
510(k)(Premarket Notification) FDA MDUFA decision goal: 90 FDA days, excluding days on hold for an Additional Information request	90 days	6-12 months	6-8 months	Verified
De Novo(De Novo Classification) For novel devices without a legally marketed predicate	150 days	8-15 months	—	Verified
PMA(Premarket Approval) The statutory PMA review period is 180 days after filing (21 CFR 814.40(a))	180 days	4-8 years	4-6 years	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

United States Medical Device Registration Process

Step-by-step FDA registration process. Total estimated timeline: 6-12 months.

Step 1: Device Classification

2-4 weeks

Determine FDA device class (I, II, or III) and identify predicate device for 510(k) submissions.

Step 2: Pre-Submission Meeting

2-3 months

Optional Q-Sub meeting with FDA to discuss testing strategy and submission requirements.

Step 3: Testing & Documentation

3-6 months

Complete biocompatibility, EMC, performance testing. Prepare technical file and 510(k) summary.

Step 4: 510(k) Submission

1 day

Submit 510(k) application to FDA via eCopy or eSTAR. Pay user fee (currently $22,381 for small business).

Step 5: FDA Review

90-180 days

FDA conducts substantive review. Average 160-176 calendar days. May issue Additional Information requests.

Step 6: 510(k) Clearance

1 day

FDA issues clearance letter (SE = Substantially Equivalent). Device can be marketed in the USA.

Summary: The United States medical device registration process through Food and Drug Administration (FDA) consists of 6 main steps: Device Classification → Pre-Submission Meeting → Testing & Documentation → 510(k) Submission → FDA Review → 510(k) Clearance.

Expedited pathways

Breakthrough Device Designation1-2 years faster than standard PMA

Priority review for innovative devices addressing unmet needs

Eligibility: Life-threatening condition, Irreversibly debilitating disease, Breakthrough technology

Pre-Submission (Q-Sub)2-3 months saved by avoiding rejections

FDA meeting to align requirements before submission

Eligibility: All device classes, Recommended for complex devices

Prior approval recognition

EU CE MarkClinical data can be leveragedIndirect

Prior 510(k)Use as predicate device3-6 months

MDSAPSubstitutes routine FDA inspections1-2 months

Key requirements