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  1. 2023年11月3日 · Section 3305 of the Omnibus -- "Ensuring Cybersecurity of Medical Devices" -- amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 524B, Ensuring Cybersecurity of Devices ...

  2. 2022年2月4日 · FDA’s Role in Keeping Medical Devices Cyber Secure. The U.S. Food and Drug Administration regulates medical devices and works aggressively to reduce cybersecurity risks in what is a rapidly ...

  3. Linkedin. The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that serves as a reference catalog for every device with a unique device identifier (UDI ...

  4. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and ...

  5. Contains Nonbinding Recommendations Draft – Not for Implementation Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for ...

  6. 2020年4月2日 · Postmarketing Surveillance Programs. Despite CDER's vigilant premarket review, active postmarketing surveillance of drug adverse effects is also essential. Because all possible side effects of a ...

  7. 2023年8月21日 · Office of Communications 10001 New Hampshire Ave Hillandale Building, 4th Fl Silver Spring, MD 20993. druginfo@fda.hhs.gov. Toll Free. (855) 543-3784. (301) 796-3400. Hours Available. CDER ...

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