FDA Regulations
The full text of FDA Food, Medical Device and Drug GMP 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 Products21CFR11: Electronic Records: Electronic Signatures21CFR108: Emergency Permit Control21CFR110: Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food21CFR111: Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding Operations for Dietary Supplements21CFR113: Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers21CFR114: Acidified Foods21CFR117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food21CFR120: Hazard Analysis and Critical Control Point (HACCP) Systems21CFR123: Fish and Fishery Products21CFR210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General21CFR211: Current Good Manufacturing Practice for Finished Pharmaceuticals21CFR801: Labeling21CFR803: Medical Device Reporting21CFR806: Med Devices; Reports of Corrections & Removals21CFR807: Establishment Registration21CFR809: In Vitro Diagnostic Products21CFR812: Investigational Device Exemptions21CFR814: Premarket Approval of Medical Devices21CFR820: Quality System Regulation21CFR821: Medical Device Tracking Requirements21CFR822: Postmarket Surveillance21CFR830: Unique Device Identification21CFR860: Classification ProceduresThe 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 dont 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.Updated all regulations to 2019 version, added CFR 85, 101, 106, 107, 112, 115, 129, 165, 310, 312, 314, 507
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 Products21CFR11: Electronic Records: Electronic Signatures21CFR108: Emergency Permit Control21CFR110: Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food21CFR111: Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding Operations for Dietary Supplements21CFR113: Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers21CFR114: Acidified Foods21CFR117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food21CFR120: Hazard Analysis and Critical Control Point (HACCP) Systems21CFR123: Fish and Fishery Products21CFR210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General21CFR211: Current Good Manufacturing Practice for Finished Pharmaceuticals21CFR801: Labeling21CFR803: Medical Device Reporting21CFR806: Med Devices; Reports of Corrections & Removals21CFR807: Establishment Registration21CFR809: In Vitro Diagnostic Products21CFR812: Investigational Device Exemptions21CFR814: Premarket Approval of Medical Devices21CFR820: Quality System Regulation21CFR821: Medical Device Tracking Requirements21CFR822: Postmarket Surveillance21CFR830: Unique Device Identification21CFR860: Classification ProceduresThe 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 dont 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.Updated all regulations to 2019 version, added CFR 85, 101, 106, 107, 112, 115, 129, 165, 310, 312, 314, 507
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