Latest update
Updated all regulations to 2019 version, added CFR 85, 101, 106, 107, 112, 115, 129, 165, 310, 312, 314, 507
FDA Regulations APK Description
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.
How to install FDA Regulations APK bundles for Android
Once you have downloaded an Android App Bundle, you can install it using a dedicated app bundle installer app. You can install .apks, .xapk, split apk files, and unencrypted .apkm files using the Split APKs Installer (SAI). SAI is considered the gold standard for installing app bundles in the Android community. Here’s how to use the SAI app to install split apks. Download FDA Regulations APK file (com.jacobkearns.fdaregulations_15_3975565.zip) from APKBundles.com, then follow these steps:
Update Phone Settings
- Go to your phone Settings page
- Tap Security or Applications (varies with device)
- Check the Unknown Sources box
- Confirm with OK
Go to Downloads
- Open Downloads on your device by going to My Files or Files
- Download Split APKs Installer (SAI)
- Download and unzip file you already downloaded (com.jacobkearns.fdaregulations_15_3975565.zip)
- Open Split APKs Installer and follow steps on this app.
- Tap Install when prompted, the APK file you downloaded will be installed on your device.
How to install FDA Regulations APK, Split APK (APK Bundles) on Windows PC 7/8/10/11 or MAC?
Download FDA Regulations APK file (com.jacobkearns.fdaregulations_15_3975565.zip) from APKBundles.com to your PC (ex: C://temp/(com.jacobkearns.fdaregulations_15_3975565.zip), then follow these steps appear on screen.
Using Emulator:
- Download And Install one Emulator Softwares (Ex: Bluestacks, GenyMotion, NoxPlayer)
- Download and unzip file com.jacobkearns.fdaregulations_15_3975565.zip.
- Using ADB or Split APKs Installer same as install for Android.
FDA Regulations APK Pros & Cons
Pros
- This app is safe, it's not require high risk permissions
- Compatible with 32 bit device (most Emulator using 32bit arch CPU)
- Compatible with 64-bit device (some android device and current Bluestacks)
Cons
Everything is good.
