Jacob Kearns Apps
FDA Regulations 1.19
This app contains the full content of the United States Food andDrug Administration (FDA) Food, Medical Device and Drug GMPRegulations. 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 orHolding Human Food 21CFR111: Current Good Manufacturing Practice inManufacturing, Processing, Packing or Holding Operations forDietary Supplements 21CFR113: Thermally Processed Low-Acid FoodsPackaged in Hermetically Sealed Containers 21CFR114: AcidifiedFoods 21CFR117: Current Good Manufacturing Practice, HazardAnalysis, and Risk-Based Preventive Controls for Human Food21CFR120: Hazard Analysis and Critical Control Point (HACCP)Systems 21CFR123: Fish and Fishery Products 21CFR210: Current GoodManufacturing Practice in Manufacturing, Processing, Packing, orHolding of Drugs; General 21CFR211: Current Good ManufacturingPractice for Finished Pharmaceuticals 21CFR801: Labeling 21CFR803:Medical Device Reporting 21CFR806: Med Devices; Reports ofCorrections & Removals 21CFR807: Establishment Registration21CFR809: In Vitro Diagnostic Products 21CFR812: InvestigationalDevice Exemptions 21CFR814: Premarket Approval of Medical Devices21CFR820: Quality System Regulation 21CFR821: Medical DeviceTracking Requirements 21CFR822: Postmarket Surveillance 21CFR830:Unique Device Identification 21CFR860: Classification ProceduresThe FDA Food, Drug, and Medical Device regulations are split up bysection, click on a section to expand that specific section. Clickagain to hide. Each section also contains a link to the FDA websitewhich contains the regulation so you can verify that it is up todate. The FDA regulations are stored on your device and don'trequire an internet connection to access. This app is a useful forauditors and as a general reference, just keep your phone handyinstead of carrying around a reference book.
