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Federal Food Drug and Cosmetic Act (FFDCA) ISOs Medical Devices

Foley Hoag LLP

In Search of Harmonization: FDA Finalizes Device CGMP Regulation Harmonization with ISO 13485:2016

Foley Hoag LLP on

On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this update represents the first update to the...more

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