Design Change Routes: 510(k), PMA Supplement, or Documentation
21 CFR 807.81(a)(3) and 21 CFR 814.39(a) set the triggers for a new 510(k) and a PMA supplement. A change that meets neither still needs a documented decision.
Each design or manufacturing change to a marketed device goes one of three ways. A wrong route has a cost in either direction. A significant change treated as routine can put a device on the market without the clearance or approval it needs. A routine change treated as a submission delays the release for a review the change did not need.
| Route | Applies when | Where it is written |
|---|---|---|
| New 510(k) | A device in commercial distribution is about to be significantly changed in design, components, method of manufacture, or intended use. The change could significantly affect safety or effectiveness, or the intended use changes in a major way. | 21 CFR 807.81(a)(3) |
| PMA supplement | A device with an approved PMA is about to change in a way that affects safety or effectiveness. The regulation lists exceptions that allow another submission or none. | 21 CFR 814.39(a) |
| Documentation only | The change meets neither trigger. The record states the change, the analysis, and the basis for the conclusion. | ISO 13485:2016 clause 7.3.9, which 21 CFR 820.10(c) requires for class II, class III, and listed class I devices |
The regulations set the triggers and the FDA’s guidance supplies the assessment. Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017) recommends a risk-based assessment first. It then sorts changes into labeling changes, technology and performance changes, and materials changes. A companion guidance from October 2017 covers software changes. For a PMA device, Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (December 2008) does the same.
The FDA’s note on the 510(k) guidance says it was issued before the QMSR took effect and encourages manufacturers to review the current QMSR. Its Appendix B still cites 21 CFR 820.30(i) and 820.70(b), which no longer exist.
A decision that needs no new submission still needs a record. The 510(k) guidance asks for the change, the reason for it, a comparison with the cleared device, the questions applied, the conclusion, and a signature. The guidance states that a yes or no answer to each question, without further detail, is not sufficient documentation.
ISO 13485:2016 clause 7.3.9 requires the review of a design change to include its effect on the inputs or outputs of risk management. A change that affects a risk control in the ISO 14971 risk management file is named in that review. The author of a change should not be the only person to classify it. A standing board of regulatory, quality, and engineering members gives the decision named owners. Written threshold criteria give every case the same test.
For your last ten design changes, which records show who decided that no new submission was needed, and on what grounds?
Sources: 21 CFR 807.81, 21 CFR 814.39, ISO 13485:2016 clause 7.3.9, and three FDA guidance documents: 510(k) changes, 510(k) software changes, and PMA modifications.