FDA Reverses HHS Action to Exempt Certain Medical Devices from 510(k) Requirements

The U.S. Food and Drug Administration (FDA) has withdrawn a January proposal by the U.S. Department of Health and Human Services (HHS) to permanently exempt 91 separate medical device types from the FDA’s 510(k) premarketing notification requirements.

According to a Notice of Withdrawal published in the U.S. Federal Register, the FDA took action to withdraw the HHS proposed exemptions in part because the HHS failed to notify the FDA of the proposed exemptions or consult with the agency. The HHS also reportedly based its exemption determinations exclusively on the number of adverse events reported for each device type in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.

The FDA notes that adverse event reports, while valuable, have limitations in making judgments about device exemptions, including incomplete or inaccurate data. The FDA also says that adverse event reports alone can be inaccurate due to underreporting of events or inaccuracies in the reports themselves.

Given the circumstances, the FDA deemed the HHS proposal was based on flawed information lacking inadequate scientific support and containing multiple errors. Hence, the determination to withdraw the proposed exemptions.

Read the FDA’s Notice of Withdrawal in connection with HHS’s January actions as published in the Federal Register.

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