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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The US Food and Drug Administration is clarifying the definition of medical devices in a draft guidance based on recent legislative updates.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.

The FDA published the draft guidance, “Referencing the Definition of 'Device' in the Federal Food, Drug and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents,” on...

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