Research Guides: Biomedical Engineering: Regulatory Resources

Regulatory Resources

Manufacturer and User Facility Device Experience (MAUDE)
FDA database on adverse events (death, serious injury or malfunction) involving medical devices, starting in 1993.
Device Advice: Comprehensive Regulatory Assistance (FDA)
Text-based resource that explains many aspects of medical device laws, regulations, guidances, and policies, encompassing the entire product life cycle.
Center for Device and Radiological Health Guidance documents (FDA)
Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a regulatory issue.
Medical Device Databases Link (FDA)
Links to various FDA medical device regulation and guidance databases. For example, there's a database on the recall of medical devices.
Environmental Protection Agency (EPA)
Provides environmental related regulation from the Environmental Protection Agency.

You may also want to search using Google because regulatory information is spread across many government websites. Use the following example, to search only US government websites:

Site:.gov hip replacement regulation

[Note: there isn't a space between the colon and the period]