21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

§ 321 - Definitions; generally

§ 331 - Prohibited acts

§ 351 - Adulterated drugs and devices

§ 353 - Exemptions and consideration for certain drugs, devices, and biological products

§ 355 - New drugs

§ 360 - Registration of producers of drugs or devices

§ 360b - New animal drugs

§ 360c - Classification of devices intended for human use

§ 360d - Performance standards

§ 360e - Premarket approval

§ 360e-1

§ 360f - Banned devices

§ 360h - Notification and other remedies

§ 360i - Records and reports on devices

§ 360j - General provisions respecting control of devices intended for human use

§ 360l - Postmarket surveillance

§ 360hh - Definitions

§ 360ii - Program of control

§ 360jj - Studies by Secretary

§ 360kk - Performance standards for electronic products

§ 360ll - Notification of defects in and repair or replacement of electronic products

§ 360mm - Imports

§ 360nn - Inspection, records, and reports

§ 360oo - Prohibited acts

§ 360pp - Enforcement

§ 360qq - Repealed. Pub. L. 105–362, title VI, § 601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285

§ 360rr - Federal-State cooperation

§ 360ss - State standards

§ 360aaa - Omitted

§ 360bbb - Expanded access to unapproved therapies and diagnostics

§ 371 - Regulations and hearings

§ 372 - Examinations and investigations

§ 373 - Records

§ 374 - Inspection

§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics

§ 381 - Imports and exports

§ 383 - Office of International Relations

§ 394 - Scientific review groups

U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE

Title 21 published on 20-Jun-2018 03:37

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 4 after this date.

  • 2018-03-21; vol. 83 # 55 - Wednesday, March 21, 2018
    1. 83 FR 12259 - Immediately in Effect Guidance for Industry; Compliance Policy for Combination Product Postmarketing Safety Reporting; Availability
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification of availability.
      The announcement of the guidance is published in the Federal Register on March 21, 2018.
      21 CFR Part 4