About FDA Regulations
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...
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.
Previous Versions
Here you can find the changelog of FDA Regulations since it was posted on our website on 2017-02-02 02:35:01.
The latest version is 1.20 and it was updated on 2024-04-22 16:10:56. See below the changes in each version.
FDA Regulations version 1.20
Updated At: 2022-10-18
Changes: Update target apk.
FDA Regulations version 1.19
Updated At: 2020-01-05
Changes: Updated all regulations to 2019 version, added CFR 85, 101, 106, 107, 112, 115, 129, 165, 310, 312, 314, 507
FDA Regulations version 1.19
Updated At: 2018-09-30
Changes: Update Android compatibility and add privacy policy.
FDA Regulations version 1.17
Updated At: 2017-11-25
Changes: Added cfrs 108, 113, 114, 117, 120, 123
FDA Regulations version 1.14
Updated At: 2017-01-01
Changes: v.1.14:Changed layout from tabs to view, added many regulations, removed interstitial ads, added apprater
Disclaimer
Official Google Play Link
We do not host FDA Regulations on our servers. We did not scan it for viruses, adware, spyware or other type of malware. This app is hosted by Google and passed their terms and conditions to be listed there. We recommend caution when installing it.
The Google Play link for FDA Regulations is provided to you by apps112.com without any warranties, representations or guarantees of any kind, so access it at your own risk.
If you have questions regarding this particular app contact the publisher directly. For questions about the functionalities of apps112.com contact us.
