Q:

How do you look up FDA registration for medical devices?

A:

Quick Answer

Look up registration for medical devices using the registration and listing search engine on the FDA.gov website, reports the U.S. Food and Drug Administration. Complete information in as many fields as you can, and click on Search. For some fields, click on their drop down arrows, and select the items that correspond to the information available to you.

Continue Reading

Full Answer

The FDA updates the registration and listing database every week, usually on Mondays, according to the FDA. If a search does not yield any information, try adjusting your search terms. Each search returns a maximum of 100 medical device establishments. Every establishment lists its foreign manufacturers if it is an importer, its importers if it is a foreign establishment and its inventory of medical devices that it processes, produces or distributes.

The listing for each medical device includes whether the device is a listing only or requires premarket notification clearance, explains the FDA. For all devices, the database includes their premarket submission numbers or product codes and listings of their current proprietary names. There are also descriptions of the devices' functions. Although the FDA lists most establishments and their medical devices in the registration and listing database, it occasionally grants waivers to companies that provide explanations about why they cannot submit information electronically.

Learn more about Law
Sources:

Related Questions

Explore