Research Guides: BME2000: Biomedical Engineering in the Clinical Environment: E. FDA Approval

Searching FDA.gov for Medical Devices

Search a variety of databases at fda.gov to gather medical device information:

Establishment Registration & Device Listing: includes medical device manufacturers registered with the FDA and medical devices listed with the FDA
- Search with trade name or Owner Name
510(k) Premarket Notification: includes devices that were introduced to commercial distribution for the first time and legally marketed devices that were changed or modified significantly that could affect its safety or effectiveness.
- Search with device name
Devices@FDA: includes cleared and approved medical device information from the FDA. It simultaneously searches PMN-510(k) and PMA-Premarket Approval. Info includes: device summary information, manufacturer, approval date, user instructions, and other consumer information.
- Search by device category, name, or manufacturer/company

FDA Approval

FDA Portal on Medical Devices: https://www.fda.gov/industry/regulated-products/medical-device-overview .

FDA's tools include the following:

FDA: Look for Labeling, Approval Order, and Summary of Safety and Effectiveness for more comprehensive device information.

Searching article databases for the phrases "medical device" and "FDA approval" retrieves interesting articles on the regulatory process more generally. Examples of articles:

Biological Mesh Implants for Abdominal Hernia Repair US Food and Drug Administration Approval Process and Systematic Review of Its Efficacy, JAMA Surgery, 2016;151(4):374-381. doi:10.1001/jamasurg.2015.5234

Considerations and Recommendations for the Introduction of Objective Performance Criteria for Transcatheter Aortic Heart Valve Device Approval, Circulation, 2016, Volume 133(21): 2086-2093. DOI: 10.1161/CIRCULATIONAHA.115.020493