FDA Extends Comment Period on Remanufacturing of Medical Devices Guidance

The U.S. Food and Drug Administration (FDA) has extended the public comment period on its recently issued draft guidance on the remanufacturing and servicing of medical devices.

According to a Notice published in the Federal Register in early August, the FDA has authorized a 30-day extension on the original 60-day comment period for its draft guidance, “Remanufacturing and Servicing Medical Devices.” Interested parties now have until September 22nd to submit their comments through the regulations.gov portal.

The FDA says that the extension was issued in response to a request to provide additional time to develop a thorough analysis of the draft guidance and that the extension now “allows adequate time for interested persons to submit comments without significantly delaying guidance on these important issues.”

Originally released in mid-June, the draft guidance provides important clarification on the terms “remanufacturing” and “servicing” to help device manufacturers determine what regulations apply in evaluating the safety and performance of remanufactured medical devices.

Read the complete text of the FDA’s draft guidance.

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