FDA Seeks Feedback on Changes to Special 510(k) Program

As part of its plan to update the Special 510(k) Program, the FDA released draft guidance for stakeholder comment. The agency is considering amending the program’s original rules that did not allow modifications to a device’s intended use or labeling.

“We are proposing to evaluate whether design and labeling changes can be reviewed under a special 510(k) by focusing on whether the method(s) to evaluate change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format,” the draft states. Any such submissions would remain subject to all other content requirements.

To be eligible for the program, the 510(k) should be for a change to the submitter’s own device, the agency said, because  the program relies on previous FDA reviews of detailed information, and a device manufacturer modifying its own device is in a position to conduct the necessary risk analyses and verification activities.