FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & Cosmetic Act (FD&C Act). The FD&C Act contains provisions, that is, regulatory requirements, that define FDA's level of control over these products. To fulfill the provisions of the FD&C Act that apply to medical devices and radiation-emitting products, FDA develops, publishes and implements regulations.
Federal Register (FR)
The FR is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. Proposed rules are initially published in the Federal Register for public comment and subsequently published in the Code of Federal Regulations after the rule is final. Final regulations published in the FR are subsequently placed or codified into the printed edition of the Code of Federal Regulations (CFR) on an annual basis. You can find recently published FR's on the Regulations.gov web page.
Code of Federal Regulations (CFR)
The CFR is a codification of the general and permanent rules that were published in the FR by the Executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation.
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, clinical evaluation, manufacturing, packaging, labeling and post market surveillance of medical devices. In addition, the regulations address standards and product reports that apply to radiation-emitting products.
- 21 CFR searchable database
- Parts 1 - 99 (product jurisdictions, protection of human subjects, institutional review boards, etc)
- Parts 100 - 799 (food, human and animal drugs, biologics, cosmetics)
- Parts 800 - 1299 (medical devices and radiation emitting products)
- Parts 1300 - 1499 (controlled substances)
The Electronic Code of Federal Regulations (e-CFR) is a currently updated version of the Code of Federal Regulations (CFR). It is not an official legal edition of the CFR. The e-CFR is an unofficial editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Printing Office. The OFR updates the material in the e-CFR on a daily basis. The current update status appears at the top of all e-CFR web pages