The FDA code of federal regulations

FDA Code of Federal Regulations (CFR) is a huge sea of regulations that the FDA has created for regulating all products that come under its purview of regulation. The FDA codes of federal regulations are numbered and cover all products, processes and the activities that go into their creation.

The FDA Code of Federal Regulations is a compendium of codified general and permanent rules the federal government’s various relevant agencies and executive departments publish in the Federal Register. It runs into 50 titles, each of which symbolizes a particular set of general and wide areas that are subject to FDA regulation. The common schedule behind these 50 titles is that the FDA updates each volume of the CFR once in a calendar year and issues these updates quarterly.

FDA Code of Federal Regulations relating to medical devices and related industries

Among these 50 regulations, what is of import to medical devices and related industries is the relevant FDA Code of Federal Regulations, contained in 21 CFR Part 11 of the FDA.

These are the regulations that are part of 21 CFR Part 11 of the FDA:

  • FDA Code of Federal Regulations relating to Food and Beverages
  • The FDA Code of Federal Regulations pertaining to food and beverages is contained in the following:
  • 21 CFR Part 1: U.S. FDA Food Facility Registration and U.S. Agent Regulations
  • 21 CFR Part 11 U.S. FDA Prior Notice Regulations
  • 21 CFR Parts 108, 109, 113, 114: U.S. FDA Food Canning Establishment & Process Filings (FCE-SID) Regulations
  • 21 CFR Part 11 U.S. FDA Food, Beverage, and Supplement Labeling Regulations
  • 21 CFR Part 11 U.S. FDA Food Contact Substances Regulations
  • FDA Code of Federal Regulations relating to Medical Devices Regulations
  • The FDA Code of Federal Regulations on medical devices covers the following:
  • 21 CFR Part 11 U.S. FDA Medical Device Establishment Registration and Device Listing Regulations
  • 21 CFR Part 11 U.S. FDA Medical Device Labeling Regulations
  • FDA Code of Federal Regulations relating to Cosmetics Regulations
  • The FDA Code of Federal Regulations for cosmetics covers the following:
  • 21 CFR Part 11 U.S. FDA Voluntary Cosmetic Registration Program
  • 21 CFR Part 11 U.S. FDA Cosmetics Labeling Regulations
  • FDA Code of Federal Regulations relating to Drugs Regulations
  • The FDA Code of Federal Regulations concerning drugs regulation has its ambit in the following:
  • 21 CFR Part 207: U.S. FDA Drug Establishment & Listing Regulations
  • 21 CFR Part 314.420: U.S. FDA Drug Master File (DMF) Regulations
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