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.
|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