United States · Medical Devices

FDA 510(k) Clearance in the United States

A practical guide to FDA 510(k) Clearance for medical devices sold in the United States: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Class II medical devices intended for U.S. marketing; Certain Class I and Class III devices requiring premarket notification

Authority

U.S. Food and Drug Administration (CDRH)

Legal basis

FD&C Act Section 510(k); 21 CFR Part 807 Subpart E

Local representative

A U.S. agent is required for foreign establishments

Timeline

FDA review timing varies; responses to questions affect the total

Cost

FDA user fees apply; testing and consultant costs vary

If you do not comply

Unauthorized marketing, detention, injunction, and civil penalties

Who needs this

Class II medical devices intended for U.S. marketing
Certain Class I and Class III devices requiring premarket notification

Documents you need

510(k) submission and cover letter
Predicate device comparison
Performance and safety testing

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

510(k) submission and cover letter
Predicate device comparison
Performance and safety testing

How to comply

Confirm the device classification and a suitable predicate
Prepare and submit the 510(k)
Respond to FDA additional information requests

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: FDA 510(k) Clearance — United States
Product category: Medical Devices
Authority: U.S. Food and Drug Administration (CDRH)
Legal basis: FD&C Act Section 510(k); 21 CFR Part 807 Subpart E

Documents we already have:
  1. 510(k) submission and cover letter
  2. Predicate device comparison
  3. Performance and safety testing

Questions:
  1. Does our product fall under FDA 510(k) Clearance in the United States?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

FDA review timing varies; responses to questions affect the total.

FDA user fees apply; testing and consultant costs vary.

Common rejection reasons

No substantial equivalence to the predicate
Insufficient performance data
Wrong predicate or device classification

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.