On July 27, 2011, the U.S. Food and Drug Administration (FDA or “the Agency”) issued the much anticipated draft guidance addressing when modifications to cleared devices require new 510(k) premarket notifications. This new draft guidance, “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device,” when finalized, would supersede the Agency’s 1997 guidance, “Deciding When to Submit a 510(k) for a Change in an Existing Device.” Overall, the updated guidance will likely result in the filing of new 510(k)s and increase the total number of 510(k)s that manufacturers need to file. We recommend that all device manufacturers review their procedures for assessing modifications to their 510(k)-cleared devices, revise those procedures as necessary, and prepare to submit any required 510(k)s for modified devices. Public comments on the draft are due October 25, 2011, and should refer to Docket No. FDA-2011-D-0453.

The draft guidance does not include the decision-tree flowcharts that were included in the 1997 guidance. Rather, the new guidance provides a series of questions for manufacturers to address when evaluating device modifications in the following categories: (1) manufacturing process changes, (2) labeling changes, (3) technology or performance changes, and (4) materials changes. (The 1997 guidance does not address manufacturing process changes.) The guidance does not address combination products or nanotechnology-specific criteria. It also does not supplant existing devicespecific guidances, such as the “Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses.”

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