FDA: Three New Draft 510(k) Guidance Documents Address Increased Complexity of Medical Devices

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FDA: Three New Draft 510(k) Guidance Documents Address Increased Complexity of Medical Devices

Dennis Tosh

September 7, 2023 at 03:26 PM EST

The FDA Sept. 6 released three draft premarket notification (510(k)) guidance documents that according to the agency are “intended to support efforts to continue to strengthen and modernize the 510(k) program and advance the safety and effectiveness of medical devices as they become more complex and innovative.” According to the FDA Center for Devices and Radiological Health ... Read More

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FDA: Three New Draft 510(k) Guidance Documents Address Increased Complexity of Medical Devices

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