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  1. Quality and Compliance (Medical Devices)

Center for Devices and Radiological Health (CDRH) Compliance Programs

Update: October 12, 2023

The FDA updated the Compliance Program Guidance Manual (CPGM) for the Inspection of Medical Device Manufacturers, Compliance Program 7382.845 to clarify current processes, incorporate new authorities, and update references and program contacts.

The FDA's compliance programs provide instructions to the FDA's investigators for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by the FDA. Compliance Programs are made available to the public under the Freedom of Information Act. Compliance Programs do not create or confer any rights for or on any person and do not operate to bind the FDA or the public. This means a different approach may be used as long as the approach satisfies the requirements of the applicable statutes and regulations.

Compliance Programs for all FDA program areas may be accessed at Compliance Program Guidance Manual (CPGM).

Program # Compliance Program Title On-Line Availability
7356.000 Inspections of CDER-led or CDRH-led Combination Products PDF (874 KB)
7382.845 Inspection of Medical Device Manufacturers PDF (634 KB)
7383.001 Medical Device Premarket Approval and Postmarket Inspections PDF (275 KB)
7385.014 Mammography Facility Inspections PDF (740 KB)
7386.001 Inspection and Field Testing of Radiation-Emitting Electronic Products (updated 01/01/23) PDF (356 KB)
7386.003 Field Compliance Testing of Diagnostic Medical X-Ray Equipment PDF (302 KB)
7386.003a Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment PDF (84 KB)
7386.006 Compliance Testing of Electronic Products at WEAC (updated 01/01/23) PDF (337 KB)
7386.007 Imported Electronic Product (under revision)
7386.008 Medical Device and Radiological Health Use Control and Policy Implementation (under revision)
7386.009 Emergency Planning and Response Activities
Part VI
(under revision)

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