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Home » FDA posts draft guidance for counterfeit devices
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FDA posts draft guidance for counterfeit devices

Dec. 20, 2021
By Mark McCarty
The COVID-19 pandemic shone an unsparing light on counterfeit devices, but the FDA has previously enjoyed only limited authority to deal with those products. Thanks to legislation passed in January 2021, the agency now has authority to destroy imported counterfeit devices, including those combined with counterfeit drugs. The agency has had authority to destroy counterfeit drugs for a number of years, but that authority did not extend to counterfeit devices until passage of the Safeguarding Therapeutics Act of 2020, which was signed into law in January 2021.
BioWorld MedTech Regulatory U.S. FDA

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