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General Controls for Medical Devices | FDA - U.S. Food …
- https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices
- The Amendments require in Section 510 that manufacturers and other specified processors of devices register their establishments with the FDA and provide to the FDA a list of all devices manufactured in any establishment which they operate. Repackers, relabelers, and importers are also required to register with th… See more
Federal Food, Drug, and Cosmetic Act (FD&C Act) | FDA
- https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
- The Federal Food, Drug, and Cosmetic Act and subsequent amending statutes are codified into Title 21 Chapter 9 of the United States Code. The listing of FD&C Act …
Federal Register :: Medical Devices; Technical …
- https://www.federalregister.gov/documents/2021/04/01/2021-06681/medical-devices-technical-amendments
- Therefore, FDA finds good cause for the amendments to become effective on the date of publication of this action. Start List of Subjects List of Subjects in 21 CFR Part …
Medical Device Amendments (1976 - S. 510) - GovTrack.us
- https://www.govtrack.us/congress/bills/94/s510
- An Act to amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other …
21 U.S. Code Chapter 9 - FEDERAL FOOD, DRUG, …
- https://www.law.cornell.edu/uscode/text/21/chapter-9
- 21 u.s. code chapter 9 - federal food, drug, and cosmetic act . u.s. code ; prev | next. subchapter i—short title (section 301) ... subchapter v—drugs and devices (§§ 351 – …
To amend the Federal Food, Drug, and Cosmetic Act to …
- https://www.govtrack.us/congress/bills/118/hr1090
- H.R. 1090: To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness. Track H.R. …
HR1090 | US Congress 2023-2024 | To amend the Federal Food, …
- https://trackbill.com/bill/us-congress-house-bill-1090-to-amend-the-federal-food-drug-and-cosmetic-act-to-enhance-medical-device-communications-and-ensure-device-cleanliness/2374761/
- US Congress HR1090 2023-2024 To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness.
H.R.1090 - To amend the Federal Food, Drug, and …
- https://www.congress.gov/bill/118th-congress/house-bill/1090/text
- As of 02/18/2023 text has not been received for H.R.1090 - To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications …
DEPARTMENT OF HEALTH AND HUMAN …
- https://public-inspection.federalregister.gov/2023-03520.pdf
- Food and Drug Administration ... Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(k)) and implementing regulations in part 807 (21 CFR …
9522 Federal Register /Vol. 88, No. 30/Tuesday, …
- https://www.govinfo.gov/content/pkg/FR-2023-02-14/pdf/2023-03070.pdf
- Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360i(f)), requiring the establishment of a unique device identification (UDI) system by FDA. …
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