Navigate US FDA medical device regulations with confidence.
Classification, submission strategy and evidence for the US market, from the first Pre-Submission to clearance or approval and the obligations that follow.
Key facts
Pathways
- 510(k) premarket notification: substantial equivalence to a legally marketed predicate
- De Novo classification request for novel low-to-moderate risk devices without a predicate
- Premarket approval (PMA) for Class III devices
- Humanitarian Device Exemption (HDE) for rare conditions
- Investigational Device Exemption (IDE) for significant-risk clinical studies
- Q-Submission programme for FDA feedback before you submit
IVD-specific routes
- CLIA categorisation, CLIA waiver by application, or dual 510(k) and CLIA waiver
- Emergency Use Authorization when a declaration is in effect
What you will need
- Device description and indications for use
- Predicate comparison (510(k)) or benefit–risk analysis (De Novo, PMA)
- Bench, biocompatibility, sterility, electrical safety, EMC and software testing as applicable
- Cybersecurity documentation for cyber devices (FD&C Act §524B)
- Labelling, and clinical data where needed
- eSTAR electronic submission template for 510(k) submissions
Sequence and decision points
- 01ClassifyIdentify the product code, classification regulation and likely pathway.
- 02Plan evidenceSelect a predicate or justify De Novo; define testing and any clinical data.
- 03Pre-SubmissionOptional Q-Sub to confirm the plan with FDA.
- 04Prepare and submitCompile the submission in eSTAR and pay the user fee.
- 05ReviewAcceptance review, substantive review and responses to additional information requests.
- 06Decision and registrationClearance, grant or approval, then establishment registration and device listing.
Quality Management System Regulation (21 CFR Part 820), which incorporates ISO 13485:2016 by reference and has applied since 2 February 2026. FDA accepts MDSAP audit reports in place of routine inspections; for-cause and PMA pre-approval inspections still apply.
Foreign establishments must designate a U.S. Agent when they register. Establishments register and list devices every year.
Where MedoQi does not hold this role, we work with your appointed representative or a qualified partner.
FDA's MDUFA performance goals are 90 FDA review days for 510(k) decisions and 150 for De Novo requests; PMA review is set at 180 days in statute. Time spent answering FDA questions is additional. User fees are published each fiscal year, with reductions for qualifying small businesses.
After market entry
- Medical Device Reporting (21 CFR 803): 30 calendar days, or 5 work days when remedial action is needed
- Reports of corrections and removals (21 CFR 806)
- UDI and GUDID data (21 CFR 830)
- Annual establishment registration and listing
- PMA annual reports and post-approval studies where required
- Section 522 post-market surveillance when ordered
How we help
- Classification, product code and predicate research
- Pre-Submission strategy and meeting preparation
- 510(k), De Novo and PMA preparation in eSTAR
- Testing strategy and report review
- QMSR readiness and mock inspections
- PCCPs for AI-enabled device software
- UDI, labelling and MDR reporting support
Delivered through our model: assess, validate, remediate, submit, maintain. How we work
Common questions about United States
Summary information for orientation. Requirements depend on intended use, classification and device characteristics, and change over time.
Does every device need a 510(k)?
No. Most Class I and some Class II devices are exempt, and novel devices without a predicate may need De Novo. The answer depends on the classification regulation and any limits on the exemption.
Can an MDSAP audit replace an FDA inspection?
FDA accepts MDSAP audit reports in place of routine inspections. It can still carry out for-cause inspections and pre-approval inspections for PMA devices.
We are outside the US. What do we need?
A U.S. Agent, establishment registration and device listing, and a QMS that meets 21 CFR Part 820, in addition to the clearance or approval itself.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.