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A Device or A Counterfeit Device, That Is The Question

The US FDA has drafted a guidance clarifying its definition of device and counterfeit device to conform with the 2020 Safeguarding Therapeutics Act.

An FDA inspector at the International Mail Facility in New York on 5 March, 2018, inspecting imports for counterfeit products
An FDA inspector at the International Mail Facility in New York on 5 March, 2018, inspecting imports for counterfeit products • Source: Alamy

The US Food and Drug Administration is clarifying the definition of medical devices in a draft guidance based on recent legislative updates. The agency is making the move to exert its Congressional authority to destroy counterfeit devices.

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