Regulatory
Special 510(k)(Special 510(k))
In one line
Streamlined 510(k) for modifications to a manufacturer's own legally marketed device.
Definition
A Special 510(k) relies on design control procedures to support a determination of substantial equivalence for changes to the submitter's own predicate, with a target FDA review goal of 30 days.
A Special 510(k) suits a change to the manufacturer's own cleared device where the methods used to evaluate the change are well established and the results can be reviewed in a summary or risk analysis format. FDA aims to complete review within 30 days. If the change needs a novel test method or detailed data review, a Traditional 510(k) is usually required instead. FDA's 2019 guidance on the Special 510(k) Program sets out the criteria.
Why it matters
Best when the modification's effects can be assessed via verification and validation methods with well-established performance criteria. Not appropriate for changes to indications for use.
Common pitfalls
- •A common pitfall is submitting a Special 510(k) for changes that significantly alter the device's technology or intended use, leading to a rejection or a request for a Traditional 510(k).
- •Misjudging the appropriate level of verification and validation needed for the modification can result in an incomplete submission.
- •Failing to clearly document the link between the design changes and the supporting verification and validation activities is a frequent mistake.
- •Assuming a 30-day review timeline is guaranteed, as the actual review time can be longer if deficiencies are identified.
- •Submitting a Special 510(k) for modifications that introduce new risks or significantly impact patient safety is inappropriate and will be rejected.
Sources
- The Special 510(k) Program · FDA
- RAPS Regulatory Focus · RAPS
- FDA - Medical Devices · FDA