Previously, FDA's Special 510(k) Program was limited to review of changes that did not affect the device’s intended use nor alter the device’s fundamental scientific technology. Under this approach, Special 510(k)s that included modifications to the indications for use or any labeling change that affected the device’s intended use and/or modifications that had the potential to alter the fundamental scientific technology of the device compared to the manufacturer’s own legally marketed predicate device were routinely converted to traditional 510(k)s.
With the new guidance, FDA said it will instead focus on whether the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format.
In addition to the recommendations in the infographic above, FDA outlined some circumstances when it is not appropriate to submit a Special 510(k), including:
- When evaluation of the change(s) to the device generally involve greater than three scientific disciplines (e.g., biocompatibility, sterility, electromagnetic compatibility);
- For multiple devices with unrelated changes as described in the FDA guidance Bundling Multiple Devices or Multiple Indications in a Single Submission;
- When a recent QS inspection has resulted in the issuance of a violative inspection report identifying observations related to design controls that are relevant to the design changes under review in the 510(k). If a manufacturer believes such violations are unrelated to the subject 510(k), they should provide a rationale for why the 510(k) should still be appropriate for review under the Special 510(k) Program;
- When Special 510(k)s are submitted for common scenarios that FDA anticipates a review of complete test reports will be necessary to establish substantial equivalence, such as:
- Changes to the indications for use that are supported by clinical, animal, or cadaver data;
- Use of novel sterilization methods as described in the FDA guidance Submission and Review of Sterility Information in 510(k) submissions for devices labeled as sterile;
- Changes to introduce initial MR Conditional labeling or significant deviations from the test methods used to establish MR Conditional labeling in the original 510(k);
- Change from single-use to reusable when reprocessing validation or human factors data should be provided; and
- Use of analytical chemistry testing using International Organization for Standardization (ISO) 10993-1820 and/or toxicological risk assessment using ISO 10993-17 21 to address biocompatibility.
- For a reprocessed single-use device (SUD) that requires the submission of cleaning, sterilization, and functional performance validation data under section 510(o) of the FD&C Act and in FDA’s Federal Register notice published in 70 FR 5691123 requiring the submission of SUD validation data. Consistent with the FDA guidance Medical Device User Fee and Modernization Act of 2002, validation data in 510(k) submissions for reprocessed SUDs if the reprocessed SUD does not require validation data and is otherwise appropriate for a Special 510(k) submission, the reprocessor may submit a Special 510(k);
- For changes that could affect the reprocessing of reusable devices required by section 510(q) of the FD&C Act to include reprocessing validation in 510(k) submissions.