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NAMSA

Month: April 2022

FDA Announces Optional Pathway for Clearance of Surgical Sutures

The FDA issued a final guidance on April 11, 2022, establishing the performance criteria for surgical sutures, allowing for clearance of devices through the Safety and Performance Based Pathway.

FDA Reissues Draft Guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”

On April 7, 2022, the U.S. Food and Drug Administration (FDA) announced the release of draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.”