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 Title | On-Line Availability |
|---|---|---|
| 7382.845 | Inspection of Medical Device Manufacturers | HTML, PDF (316 KB) |
| 7383.001 | Medical Device Premarket Approval and Postmarket Inspections | HTML, PDF (275 KB) |
| 7385.014 | Mammography Facility Inspections | HTML, PDF (740 KB) |
| 7386.001 | Inspection and Field Testing of Radiation-Emitting Electronic Products | HTML, PDF (356 KB) |
| 7386.003 | Field Compliance Testing of Diagnostic Medical X-Ray Equipment | PDF (80 KB) |
| Attachments A-C | PDF (16 KB) | |
| Attachment D | PDF (32 KB) | |
| Attachment E | PDF (72 KB) | |
| Attachment F | PDF (36 KB) | |
| Attachment G | PDF (32 KB) | |
| Attachments H-K | PDF (28 KB) | |
| Attachment L | PDF (12 KB) | |
| Attachment M | PDF (40 KB) | |
| 7386.003a | Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment | HTML, PDF (84 KB) |
| 7386.006 | Compliance Testing of Electronic Products at WEAC | (under revision) |
| 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) |
Back to FDA Compliance Program Guidance Manual
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