This app contains the full content of the United States Food and Drug Administration (FDA) Medical Device and Drug GMP Regulations. The following Title 21 Parts are included:
21CFR4: Regulation of Combination Products 21CFR11: Electronic Records: Electronic Signatures 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 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 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 Medical Device and Drug 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.
Very useful. Good work.
Developer is excellent. Ask for 210 & 211 and...BAM... there it is
This is good app for gaining knowledge about CFR to all persons