FDA Regulatory Procedures Manual
TABLE OF CONTENTS
INTRODUCTION
1 REGULATORY ORGANIZATION
1-1 INTRODUCTION
1-2 OFFICE OF REGULATORY AFFAIRS (ORA)
1-3 CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
1-4 CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
1-5 CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
1-6 CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)
1-7 CENTER FOR VETERINARY MEDICINE (CVM)
1-8 ENFORCEMENT POLICY DIRECTORY
2 FDA AUTHORITY
2-1 THE U.S. FEDERAL JUDICIAL SYSTEM
2-2 SELECTED AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND
COSMETIC ACT
2-3 OTHER LAWS
3 COMMISSIONING AND WORK SHARING
3-1 INTRODUCTION; OBJECTIVES
3-2 AUTHORITIES
3-3 CONSIDERATIONS BEFORE COMMISSIONING
3-4 DOCUMENTATION; CREDENTIALS
3-5 CONFLICT OF INTEREST
3-6 CONFIDENTIALITY
3-7 CONSIDERATIONS AFTER COMMISSIONING
3-8 ADMINISTRATIVE CONSIDERATIONS
3-9 ACCEPTING A STATE’S COMMISSION
3-10 WORK SHARING
3-11 EXHIBITS
4 ADVISORY ACTIONS
4-1 WARNING LETTERS
4-2 UNTITLED LETTERS
4-3 EXHIBIT
5 ADMINISTRATIVE ACTIONS
5-1 CITATIONS
5-2 SECTION 305 MEETING
5-3 ADMINISTRATIVE DETENTION OF FOOD
5-4 DETENTION OF FOODS – OTHER STATUTORY AUTHORITY
5-5 ADMINISTRATIVE DETENTION OF DEVICES
5-6 LICENSE REVOCATION OR SUSPENSION
5-7 ORDERS OF RETENTION, RECALL, DESTRUCTION, AND CESSATION
OF MANUFACTURING RELATED TO HUMAN CELL, TISSUE, AND CELLULAR
AND TISSUE-BASED PRODUCTS (HCT/PS)
5-8 CIVIL MONEY PENALTIES
5-9 EXHIBITS
6 JUDICIAL ACTIONS
6-1 SEIZURE
6-2 INJUNCTIONS
6-3 INSPECTION WARRANTS
6-4 SEARCH WARRANTS
6-5 PROSECUTION
6-6 CIVIL PENALTIES – ELECTRONIC PRODUCT RADIATION CONTROL
6-7 EXHIBITS
7 RECALL PROCEDURES
7-1 PURPOSE
7-2 BACKGROUND
7-3 SUMMARY OF FDA RESPONSIBILITIES AND PROCEDURES
7-4 RECALL ENTERPRISE SYSTEM
7-5 INITIATION OF A RECALL
7-6 RECALL CLASSIFICATION AND STRATEGY
7-7 NOTIFICATIONS AND PUBLIC WARNING
7-8 MONITORING AND AUDITING RECALL EFFECTIVENESS
7-9 RECALL TERMINATION
7-10 ATTACHMENTS AND EXHIBITS
8 EMERGENCY PROCEDURES
8-1 PURPOSE
8-2 INTRODUCTION
8-3 RESPONSIBILITY
8-4 NOTIFICATION OF EMERGENCIES
8-5 DISTRICT OPERATING PROCEDURE
8-6 HEADQUARTERS OPERATING PROCEDURES
8-7 INTERAGENCY COORDINATION
8-8 PRESS RELATIONS
8-9 REFERENCES
8-10 ATTACHMENT AND EXHIBIT
9 IMPORT OPERATIONS AND ACTIONS
9-1 IMPORT PROCEDURES
9-2 COVERAGE OF PERSONAL IMPORTATIONS
9-3 IMPORTATION OF BIOLOGICAL PRODUCTS
9-4 FDA NATIONAL IMPORT PROCEDURE REGARDING WAREHOUSE
ENTRIES
9-5 RELEASE NOTICES
9-6 DETENTION WITHOUT PHYSICAL EXAMINATION (DWPE)
9-7 NOTICE OF DETENTION AND HEARING
9-8 RESPONSE (HEARING) TO NOTICE OF DETENTION AND HEARING
9-9 NOTICE OF REFUSAL OF ADMISSION
9-10 RECONDITIONING
9-11 SUPERVISORY CHARGES
9-12 BOND ACTIONS
9-13 IMPORT INFORMATION DIRECTIVES
9-14 PRIORITY ENFORCEMENT STRATEGY FOR PROBLEM IMPORTERS
9-15 IMPORT FOR EXPORT
9-16 IMPORTATIONS FOR TRADE SHOWS/FAIRS, EXHIBITS AND SPECIAL
EVENTS
9-17 SECURED STORAGE (TEMPORARY REMOVAL DUE TO PENDING
REVISION)
9-18 COMMUNICATION CONCERNING ASSESSMENT OF CIVIL
MONETARY PENALTIES BY CBP IN CASES INVOLVING IMPORTED FOOD
9-19 NOTICE OF SAMPLING
9-20 GRANTING AND DENYING TRANSPORTATION AND EXPORTATION
(T&E) ENTRIES
9-21 EXHIBITS
10 OTHER PROCEDURES
10-1 COMMUNICATIONS - DISTRICT AND CENTER RESPONSIBILITIES
10-2 PRIOR NOTICE
10-3 REGULATORY MEETINGS
10-4 INSPECTION OF FOOD RECORDS - SECTIONS 414(A) AND 704(A)
10-5 ESTABLISHMENT INSPECTION REPORT (EIR) CONCLUSIONS AND
DECISIONS
10-6 INTERSTATE TRAVEL PROGRAM (ITP) CLASSIFICATIONS AND
ADMINISTRATIVE ACTIONS
10-7 REPORTING AND MONITORING
10-8 AD HOC COMMITTEE
10-9 APPEAL PROCESS
10-10 EXPERT SUPPORT FOR CASES
10-11 TESTIMONY; PRODUCTION OF RECORDS; CERTIFICATION OF
RECORDS
10-12 APPLICATION INTEGRITY POLICY
11 GLOSSARY
APPENDIX A RPM CHANGE REQUEST FORM