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U.S. Department of Health and Human Services

Medical Devices

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Center for Devices and Radiological Health (CDRH) Compliance Programs

FDA's Compliance Programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by 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 FDA or the public. An alternative 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
http://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/default.htm.

Program #Compliance Program TitleOn-Line Availability
7382.845Inspection of Medical Device ManufacturersHTML, PDF (316 KB)
7383.001Medical Device Premarket Approval and Postmarket InspectionsHTML, PDF (275 KB)
7385.014Mammography Facility InspectionsHTML, PDF (740 KB)
7386.001Inspection and Field Testing of Radiation-Emitting Electronic ProductsHTML, PDF (356 KB)
7386.003Field Compliance Testing of Diagnostic Medical X-Ray EquipmentPDF (80 KB)
Attachments A-CPDF (16 KB)
Attachment DPDF (32 KB)
Attachment EPDF (72 KB)
Attachment FPDF (36 KB)
Attachment GPDF (32 KB)
Attachments H-KPDF (28 KB)
Attachment LPDF (12 KB)
Attachment MPDF (40 KB)
7386.003aInspection of Domestic and Foreign Manufacturers of Diagnostic X Ray EquipmentHTML, PDF (84 KB)
7386.006Compliance Testing of Electronic Products at WEAC(under revision)
7386.007Imported Electronic Product(under revision)
7386.008Medical Device and Radiological Health Use Control and Policy Implementation(under revision)
7386.009Emergency Planning and Response Activities
Part VI
(under revision)

Back to FDA Compliance Program Guidance Manual