Remanufacturing Guidance Adds Info On Premarket Requirements For Remanufacturers

Clarification needed on software

After clarifying what a remanufactured device is in its 2021 draft guidance, FDA’s final guidance adds information about regulatory requirements for companies whose devices qualify as remanufactured.

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The US Food and Drug Administration’s final guidance on remanufacturing devices now includes regulatory requirements and considerations for devices that are considered remanufactured.

The final guidance, Remanufacturing of Medical Devices, was published on 10 May and replaces the June 2021 document. The...

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