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Guide to Medical Device Regulation

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RECENT UPDATES

Apr 29, 2024
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564 (Draft Guidance — May 6, 2024) (draft guidance added).
Apr 29, 2024
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency (Draft Guidance — May 6, 2024) (draft guidance added).
Apr 24, 2024
Top 10 Recent FDA & DEA Developments — And What's Next in 2024 (white paper added).
Apr 16, 2024
¶233 — Computer Products and Mobile Medical Applications (information added on draft FDA guidance for complying with regulatory mandates for cyber devices enacted under the Food and Drug Omnibus Reform Act of 2022 (FDORA)).
Apr 16, 2024
¶432 — Classification of Post-Amendments Devices (information added on a March 2024 FDA draft guidance document on requests for feedback and meetings with agency staff in connection with device submissions under the Q-Submission Program).

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