FDA Issues Guidance on Device Exemptions from Pre-Market Notification Requirements

The U.S. Food and Drug Administration (FDA) has issued a final guidance clarifying the types of medical devices that are exempt from its premarket notification requirements.

Published on February 8, the final guidance, “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements,” identifies product codes for specific types of medical devices that the agency deems to be “low-risk.” Under authority granted to the FDA under prior legislation, including the 21st Century Cures Act, the FDA will exempt these devices from its 510(k) requirements.

According to a press release announcing the publication of the final guidance, the FDA is expected to publish a final rule codifying these exemptions. Until then, the FDA says that it “does not intend to enforce compliance with 510(k) requirements for these devices and does not expect manufacturers to submit 510(k)s for these devices.”

However, the FDA also notes that medical devices that are exempt from 510(k) requirements must still meet other regulations, including the registration and listing of devices, good manufacturing practice requirements and reporting requirements.

Read the complete text of the FDA’s latest guidance applicable to medical devices.

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