FDA Predicate Rules

Predicate rules are the requirements that can be found in part 21 CFR Food and Drugs regulations. They are basically promulgated under the authority of the Food Drug and Cosmetic Act or under the authority of the Public Health Service Act. The most well-known FDA regulations are the GLP and GMP regulations but there are many more. All FDA regulations can be downloaded from the FDA website but sometimes they are not easy to find. Here you can find a list and links to 23 FDA regulations.

Food

 

21 CFR 106

Infant Formula Quality Control Procedures

 

21 CFR 107

Infant Formula

 

21 CFR 110

Current Good Manufacturing Practice in Manufacturing, Packing and Holding Human Food

 

21 CFR 113

Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers

 

21 CFR 114

Acidified Foods

 

21 CFR 123

Fish and Fishery Products

 

21 CFR 129

Bottled Drinking Water

GLP

 

21 CFR 58

Good Laboratory Practice for Non-clinical Laboratory Studies

GMP

 

21 CFR 210

Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs

 

21 CFR 211

Current Good Manufacturing Practice For Finished Pharmaceuticals

GCP

 

21 CFR 50

Protection of Human Subjects

 

21 CFR 54

Financial Disclosure by Clinical Investigators

 

21 CFR 56

Institutional Review Boards Table of Contents

New Drugs

 

21 CFR 310

New Drugs

 

21 CFR 312

Investigational New Drug Application

 

21 CFR 314

Applications for FDA Approval to Market a New Drug

 

21 CFR 510

New Animal Drugs

 

21 CFR 511

New Animal Drugs For Investigational Use

 

21 CFR 514

New Animal Drug Applications

 

Medical Devices

 

21 CFR 803

Medical Device Reporting

 

21 CFR 806

Medical devices Reports of Corrections and Removals

 

21 CFR 808

Exemptions from Federal Preemption of State and Local Medical Device Requirements

 

21 CFR 814

Premarket Notification

 

21 CFR 820

Quality System Regulation

Other FDA Regulations

 

21 CFR 1

Exports: Notification and Recordkeeping Requirements

 

21 CFR 11

Electronic Records/Electronic Signatures