The FDA assures that the medical devices available in the United States are safe and effective. In meeting this charge, the agency promotes the development and production of high-quality devices by medical device manufacturers.
When medical device manufacturers or their products do not comply with medical device laws, the FDA can and does take action to enforce those laws. But, relying only on enforcement action does not translate to high-quality medical devices on the U.S. market.
To promote quality design and manufacturing practices, and to provide options on demonstrating compliance, the FDA has implemented the following programs:
Through these initiatives, the FDA works with industry and other stakeholders to identify barriers to medical device quality and develop innovative ways to remove those barriers, affording patients access to high-quality medical devices.
FDA's Medical Device Compliance Programs
- Office of Product Evaluation and Quality
- Postmarket Benefit-Risk Final Guidance (PDF - 870KB)
- Bioresearch Monitoring
- List of Device Recalls
- Device Registration and Listing
- Importing and Exporting Devices
- Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
- Center for Devices and Radiological Health (CDRH) Compliance Programs