Compliance Program Guidance Manual
(public access version)
Content updated: 2008-11-24
FDA compliance programs provide guidance and instructions
to FDA staff for obtaining information to help fulfill agency plans in the specified
program area. These compliance programs neither create or confer any rights for, or
on, any person and do not operate to bind FDA or the public. Alternative approaches may be
used as long as said approaches satisfy the requirements of applicable statutes and
regulations. These programs are intended for FDA personnel but are made available
electronically to the public as they become available. |
Numerical listing of all FDA Compliance Programs with hyperlinks to
those available electronically on FDA websites, organized by these program areas:
Reference:
FDA
Freedom of Information Act Handbook for Requesting Information and Records from FDA
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Program # |
Compliance Program Title |
On-line Availability |
7341.002 |
Inspection of Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) |
Link to CBER list |
7341.002A |
Inspection of Tissue Establishments |
Link to CBER list |
7342.001 |
Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors |
Link to CBER list |
7342.002 |
Inspection of Source Plasma Establishments |
Link to CBER list |
7342.007 |
Imported CBER-Regulated Products |
Link to CBER list |
7342.007A |
Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) |
Link to CBER list |
7342.008 |
Inspections of Licensed Viral Marker Test Kits |
Link
to CBER list
or (3129 kb) |
7345.848 |
Inspection of Biological Drug Products |
Link to CBER list |
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Program # |
Compliance Program Title |
On-line Availability |
7348.001 |
In Vivo Bioequivalence |
(78 kb) |
7348.808 |
Good Laboratory Practice (Nonclinical Laboratories) |
(117 kb) |
7348.808A |
Good Laboratory Practice Program (Nonclinical Laboratories)
EPA Data Audit Inspections |
(38 kb) |
7348.809 |
Institutional Review Board |
(293 kb) |
7348.809A |
Radioactive Drug Research Committee |
not on-line |
7348.810 |
Sponsors, Contract Research Organization and Monitors |
(80 kb) |
7348.811 |
Clinical Investigators |
(2437 kb) |
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Program # |
Compliance Program Title |
On-line Availability |
7346.832 |
Pre-Approval Inspections/Investigations |
(156kb) |
7346.843 |
Post-Approval Audit Inspections |
(159kb) |
7352.002 |
New Drugs (Rx) Not Covered by Approved NDA's |
not on-line |
7352.004 |
In Vitro Methods Development and Validation for Generic Drugs |
not on-line |
7353.001 |
Enforcement of the Postmarketing Adverse Drug Experience
Reporting Regulations |
|
7356.002 |
Drug Manufacturing Inspections |
(80 kb) |
7356.002A |
Sterile Drug Process Inspections |
(79 kb) |
7356.002B |
Drug Repackers and Relabelers |
(189 kb) |
7356.002C |
Radioactive Drugs |
(187 kb) |
7356.002E |
Compressed Medical Gases |
(249 kb) |
7356.002F |
Active Pharmaceutical Ingredients |
(252 kb) |
7356.002M |
Inspections of Licensed Biological Therapeutic
Drug Products |
(89 kb)
|
7356.008 |
Postmarket Drug Product Surveys |
not on-line |
7356.014 |
Drug Listing |
not on-line |
7356.014A |
Drug Listing - Labeling Review |
not on-line |
7356.020 |
Compendial Monographs Evaluation and Development (CMED) |
not on-line |
7356.020A |
Compendial Methods Assessment |
not on-line |
7356.021 |
Drug Quality Reporting System NDA Field Alert Reporting |
not on-line |
7356.022 |
Enforcement of the Prescription Drug Marketing Act (PDMA) |
not on-line |
7356.818 |
Government-Wide Quality Assurance |
not on-line |
7361.003 |
OTC Drug Monograph Implementation |
(76 kb) |
7363.001 |
Fraudulent Drugs |
(69 kb) |
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Program
# |
Compliance Program
Title |
On-line
Availability |
7382.008 |
Monitoring Devices of Foreign Origin
Import |
not on-line |
7382.013 |
Conformance Assessment of Devices to
Product Specifications in Pre-Market Notifications (510(k)s) |
not on-line |
7382.845 |
Inspection of Medical Device Manufacturers |
|
7383.001 |
Medical Device Premarket Approval and
Postmarket Inspections |
not on-line |
7383.003 |
510(k) Premarket Approval Inspections |
not on-line |
7385.014 |
Mammography Facility Inspections |
(497 kb) (730 kb) |
7386.001 |
Inspection and Field Testing
of Radiation-Emitting Electronic Products |
(1190 kb) |
7386.003 |
Field Compliance Testing of Diagnostic
Medical X-Ray Equipment |
(75 kb) (143 kb) |
Attachments A-C |
(9 kb)
(28 kb) |
Attachment D |
(25 kb)
(53 kb) |
Attachment E |
(672 kb)
(126 kb) |
Attachment F |
(30 kb)
(122 kb) |
Attachment G |
(27 kb)
(61 kb) |
Attachments H-K |
(22 kb)
(46 kb) |
Attachment L |
(7 kb)
(24 kb) |
Attachment M |
(37 kb)
(74 kb) |
7386.003a |
Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment |
Link to CDRH List
or (3.51 kb) |
7386.006 |
Compliance Testing of Electronic Products
at WEAC |
not on-line |
7386.007 |
Imported Electronic Product |
not on-line |
7386.007A |
Imported Non-certified Radiation-Emitting
Electronic Products (Special Exemption for Television Receivers,
Microwave Ovens, and Certain Class I Laser Products |
not on-line |
7386.008 |
Medical Device and Radiological Health Use Control
and Policy Implementation |
not on-line |
7386.009 |
Emergency Planning and Response Activities
Part VI |
not on-line |
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