Biomedical Engineering and Design
Regulations and Standards
From 21 USC 321
- Title 21 of the United States Code (USC) is "Food and Drugs"
- Part 321 is "Definitions, generally"
- Under that, (h) gives the definition of "device":
A "device" is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
Where are the regulations that cover medical devices?
The Federal Register (FR) [in HeinOnline]
- The main source of the U.S. government agencies' rules -- proposed new rules, changes to existing rules, and final rules
- Updated daily
- Divided into four categories: (1) presidential documents, executive orders, and proclamations; (2) rules and regulations; (3) proposed rules; and (4) notices (e.g., announcements of hearings open to the public)
The U.S. Code of Federal Regulations (CFR) [in HeinOnline]
- The CFR is the list of the permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government
- Divided into 50 titles by broad subject area (e.g., Title 21 is "Food and Drugs")
The Food and Drug Administration (FDA)
- The FDA home page lists their categories, including medical devices, with links to guidance and other necessary information.
- Note Device Advice: Comprehensive Regulatory Assistance
NEWS and INTERNATIONAL
- The Medical Device Manufacturers Association (MDMA) is a source for news about regulatory action having to do with devices
- See other news sources here (entire list of news sources) and here (the first two links are for business news)
- WHO's listing of medical device environment around the world
Here are the descriptions of device classifications in the CFR:
- Class I - General controls apply
- Class II - General and special controls apply
- Class III - General controls apply and pre-market approval (PMA) required
Medical Device Reporting (MDR) -- This site is about the FDA's procedures and information about postmarket surveillance used to "monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments" of medical devices