May 5, 2017 · However, a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices …

Promote and protect health Covers foods, drugs, biologics, cosmetics, animal and veterinary medicine, and tobacco CDRH regulates medical devices and radiation-emitting products

Aug 14, 2025 · From the simple tongue depressor in your doctor’s office to the complex pacemaker that could save your life, medical devices shape modern healthcare. The FDA …

Medical device manufacturers are subject to a range of regulatory controls (i.e., requirements) to ensure that devices are not adulterated or misbranded and to otherwise assure their safety …

However, a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high …

Thompson's Guide to Medical Device Regulation contains the highest quality analyses on the regulation of medical devices — including how the courts and the FDA interpret and enforce …

Learn more about the eCFR, its status, and the editorial process.

Facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer …

Apr 17, 2025 · In the United States, Congress has granted the FDA significant but defined authority to test, monitor, and classify medical devices, subject to statutory requirements and …

Most of FDA's medical device and radiation-emitting product regulations are in Title 21 CFR Parts 800-1299. These final regulations codified in the CFR cover various aspects of design,...