BME Capstone 370 & 371

To find regulations from an agency, a good start is to:

• Go to the web pages of that agency
• For example:
  • U.S. Food and Drug Administration. Regulatory Information
  • CDC (U.S. Centers for Disease Control and Prevention) Regulations
  • U.S. Department of Health and Human Services. Laws & Regulations
• With this approach, you must know the agencies with authority for the area of interest.

Another approach:

• For U.S. federal agencies, regulations are announced in the Federal Register and compiled in the Code of Federal Regulations (CFR).
  • Federal Register - govinfo.gov.  Announcements of proposed and new regulations. Starting with v.1, 1936.
  • Code of Federal Regulations.   Current codified regulations from the U.S. federal government. This product is from the U.S. Government Printing Office.

HeinOnline is a product that makes it easier (usually) to use the Federal Register and the Code of Federal Regulations.

"Regulations" usually refers to U.S. federal regulations, though other countries, U.S. states, and institutions (such as universities) also have regulations.  These govern the actions of those under the jurisdiction of the issuing body.

Federal regulations result from the power granted to agencies of the federal executive branch to put in place rules and policies that have the force of law.  There is a process.  For most regulations, the responsible agency:

• Announces a newly-proposed regulation or regulation change in the Federal Register,
• Receives public comment,
• Issues notice of the final regulation in the Federal Register.

The rules published in the Federal Register are codified (brought together) in an annual set called the Code of Federal Regulations (CFR) and into the eCFR --- a version that is kept current but does not claim official status. The CFR is a compilation of regulations; that is, older material is updated to reflect newer regulatory decisions.  These two titles are used as complementary; a regulation announced for comment may be completely new but often serves to update existing regulations.  Likewise, regulations in the CFR may have been updated by actions reflected in the Federal Register.

The CFR is divided into 50 titles (or subject areas) of federal regulation. Each title is divided into chapters, which are assigned to the agencies that issue regulations pertaining to that subject area. Each chapter is divided into parts; each part is then divided into sections. 

(See An Overview of Federal Regulations and the Rulemaking Process from the Congressional Research Service for details on the regulatory process.)