FDA Regulations

Note: This app does not represent a government entity, it is a copy and paste of regulations from the FDA.gov website.

This app contains the full content of the United States Food and Drug Administration (FDA) Food, Medical Device and Drug GMP Regulations. The following Title 21 Parts are included:

21CFR4: Regulation of Combination Products

21CFR11: Electronic Records: Electronic Signatures

21CFR108: Emergency Permit Control

21CFR110: Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food

21CFR111: Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding Operations for Dietary Supplements

21CFR113: Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers

21CFR114: Acidified Foods

21CFR117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

21CFR120: Hazard Analysis and Critical Control Point (HACCP) Systems

21CFR123: Fish and Fishery Products

21CFR210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

21CFR211: Current Good Manufacturing Practice for Finished Pharmaceuticals

21CFR801: Labeling

21CFR803: Medical Device Reporting

21CFR806: Med Devices; Reports of Corrections & Removals

21CFR807: Establishment Registration

21CFR809: In Vitro Diagnostic Products

21CFR812: Investigational Device Exemptions

21CFR814: Premarket Approval of Medical Devices

21CFR820: Quality System Regulation

21CFR821: Medical Device Tracking Requirements

21CFR822: Postmarket Surveillance

21CFR830: Unique Device Identification

21CFR860: Classification Procedures

The FDA Food, Drug, and Medical Device regulations are split up by section, click on a section to expand that specific section. Click again to hide. Each section also contains a link to the FDA website which contains the regulation so you can verify that it is up to date.

The FDA regulations are stored on your device and don't require an internet connection to access.

This app is a useful for auditors and as a general reference, just keep your phone handy instead of carrying around a reference book.