Title: Regulations
Course: BTEC-1300-301-302-303-F21 > Section: Regulations and Medical Devices

Regulations establish standards or requirements of conduct and provide details of how the law is to be followed. Regulations are developed through the rulemaking process and they have the force of law.

By law, anyone can participate in the process of rulemaking. Public comments are gathered through proposed rules or petitions. The FDA considers the public's comments, then drafts final rules. Final rules become federal regulations upon codification in the Code of Federal Regulations.

Title 21 of the Code of Federal Regulations is where the FDA details how they enforce the laws enacted by congress that govern their activity and authority.

Federal Register

The National Archives and Records Administration publishes a newspaper that contains federal agency regulations, proposed rules and notices, executive orders, proclamations, and other presidential documents.

The Federal Register, published each business day, informs citizens of their rights and obligations. In order for a new regulation to be officially published in the Federal Register, first a preannouncement or proposed new rule is published, followed by a public comment period. Once the comment period is over and the FDA has taken the public comments into consideration, then the final rule is published in the federal register, followed by the updating the appropriate sections of the Code of federal regulations.

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.