FDA updates recommendations for device modification protocols

The Food and Drug Administration issued a draft of updated recommendations intended to clarify when manufacturers should report medical device changes to the agency.

The draft recommendations contain guidelines for when manufacturers are required to notify the FDA regarding modifications made to medical devices already on the market.

The document specifies when these changes are extensive enough to justify FDA review.

"Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review, " said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health.

Once finalized, the guidance will replace an earlier one issued in 1997.

The FDA also issued a separate draft guidance to address software changes made to devices.

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