Special 510(k)
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.What this means in practice
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.Examples
- A manufacturer updates the software of a cleared infusion pump to improve the user interface without changing the essential performance or safety algorithms, submitting a Special 510(k) supported by software verification and validation documentation.
- A company modifies the material of a component in a cleared surgical instrument to enhance durability, demonstrating equivalence through material testing and biocompatibility data via a Special 510(k).
- A MedTech firm makes a minor dimensional change to a cleared orthopedic implant that does not affect its fit or function, submitting a Special 510(k) with engineering analyses and test results.
- •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.
Frequently asked questions
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Structured process governing the design of medical devices.
More in Regulatory
· Same categoryTwo alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.
FDA framework for nonprescription drugs with approved additional conditions needed for appropriate self-selection or actual use when labeling alone is insufficient.
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Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1The Special 510(k) ProgramTier 2 VerifiedFDAfda.gov
- 2RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
- 3FDA - Medical DevicesTier 2 VerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.