The FDA is responsible for assuring medical devices available in the United States are safe and effective throughout their total product lifecycle. In meeting this charge, the FDA promotes the development and production of high-quality medical devices. The FDA also recognizes that proper maintenance, repair, and servicing of medical devices is critical to maintaining the safe, effective, and reliable performance of devices used in the health care system.
The FDA has established Quality System Regulations (QSR) addressing device design and validation as well as good manufacturing practices. The FDA’s regulations also address complaint investigations and other means of surveilling device performance. The FDA works with manufacturers to help them achieve regulatory compliance, and takes enforcement action as appropriate.
The FDA takes enforcement action to bring medical device manufacturers into compliance when manufacturers may not be complying with medical device laws. However, relying on enforcement actions alone does not necessarily lead to or result in manufacturers focusing on improving the quality of their products.
To promote quality design and manufacturing practices, and to provide options to demonstrate compliance, the FDA has implemented programs such as the Case for Quality. Through such 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 Quality and Compliance Tools
- Medical Device Single Audit Program
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance and Enforcement Decisions (Guidance)
- 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