PMA readiness: closing DHF gaps before the audit
A premarket approval puts your design history under the closest scrutiny it will face. Close the gaps inspectors find first, before they find them.
PMA readiness means your design history can prove, without reconstruction, that every requirement was designed, verified and validated under control. Before a premarket approval application, close the gaps inspectors find first: missing traces, unsigned reviews, superseded documents still in circulation, and verification results that no longer match the design they claim to cover.
What a PMA asks of your design history
Premarket approval is the FDA's most stringent route to market, used for most Class III devices. The application must give valid scientific evidence that the device is safe and effective, and FDA normally inspects your quality system, including design records, before approving it. Your design history is where that evidence either holds together or does not.
The gaps found first
- Broken traces. Requirements with no verification, or tests that trace to requirements that have since changed.
- Missing approvals. Documents in use that were never formally reviewed and signed.
- Version confusion. Several copies of one document, and no clear answer to which one was approved.
- Stale evidence. Verification reports run against an earlier design revision.
- Risk drift. Risk controls that no longer match the requirements meant to implement them.
A readiness checklist
- Every design input traces to a design output and to verification.
- Every user need traces to validation.
- Every hazard traces to a risk control, and every risk control to a requirement and a test.
- Every controlled document has one approved, current version, with its review and signatures recorded.
- Every verification result names the design revision it tested.
- Every design change since the last review is recorded with its rationale.
Closing gaps without stopping development
Run the checklist against the traceability matrix first, because it shows where the gaps are in one view. Fix the highest-risk gaps first, record remediation honestly rather than backdating anything, and move the documents you touch into a controlled system so the same gaps cannot reopen. See our guide to DHF remediation for the detail.
How Traceable helps
Traceable keeps requirements, risks and tests linked with TraceIDs, surfaces broken traces, and publishes each approved document as a locked PDF with its signatures, so the checklist above is a view rather than a project. See how it works for medical device teams.
Related guides
This guide is educational and does not certify any product or organisation.
Common questions
What is a PMA?
Premarket approval (PMA) is the FDA review process for most Class III medical devices. The application must give valid scientific evidence that the device is safe and effective for its intended use.
Will the FDA inspect our design records?
FDA normally carries out a pre-approval inspection of your quality system, including design records, before approving a PMA. Since 2 February 2026 it inspects them under the QMSR, which applies ISO 13485:2016, so your design history should be ready to show at any point, not assembled on request.
Where should we start if the gaps are large?
Start with the traceability matrix to see the gaps in one place, then fix them in order of risk. Record remediation as remediation, dated when it is done.
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