Research Guides: BME 1: Introduction to Biomedical Engineering: FDA/Regulatory

Access key

Access requires an active UCInetID and password.

Access available to all on-campus. Off-campus access requires VPN (active UCInetID).

Access available to all.

Note about FDA information for BME 1

The information provided in class lectures contains all that you need for BME 1’s projects. The information/links below are provided if you wish to dig deeper and for your general edification.

FDA medical device databases

Search for Product Classification by type of device or product

You can do a keyword search to see if there is an existing product classification for your type of product that you can use.

Product Classification
Contains medical device names and associated classifications, including product code and device class.

Tip: Don’t be too specific. If you’re looking for a glucose monitor, just search “glucose” because it could be listed as a monitor or a meter, or something else

Search by similar known product

If you know a similar product has gone through a PMA or 510(k) process, you can enter the company name as the “Applicant” to see if you can find a similar product listed

Premarket Approval (PMA)
Database of all Premarket Approvals (PMA) that are required of all Class III devices, with multiple searchable fields. Updated every week.

More information on Premarket Approval (PMA)

510(k) Premarket Notification
This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. The database is updated once a week.

More information on Premarket Notification 510(k)