U.S. FDA Issues Draft Guidance on Special 510(k) Program

The U.S. Food and Drug Administration (FDA) has published a draft guidance intended to aid certain medical device manufacturers in retaining approval of previously authorized devices when making certain modifications to those devices.

The FDA’s Special 510(k) program was originally implemented in the late 1990s and is intended to provide an optional pathway for manufacturers seeking to make “certain well-defined modifications” to devices that have already been cleared for sale under the FDA’s 510(k) pre-market review program. Modifications allowed under the scope of the Special 510(k) program are generally limited to those that would not require retesting to evaluate the impact of those changes.

Published in late September, the guidance, titled “The Special 510(k) Program—Draft Guidance for Industry and Food and Drug Administration Staff,” provides a useful “decision-tree” graphic that can help manufacturers determine whether a modified device might be appropriate for review under the Special 510(k) program. The guidance also provides answers to frequently asked questions about the program and includes a number of informative appendices that provide additional specifics about the program’s review process.

Read the complete text of the draft guidance on the FDA’s Special 510(k) program.

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