Claris Law Legal Blogging Community

Name:

E-mail:

Phone Number:

Zip Code:

Your Question:

Editor: Marc Jay Bern
Profession: Defective Medical Device Lawyer

Category: Medtronic News

A recently released report shows the FDA has become faster at approving applications from medical device makers, such as Medtronic Inc., Baxter International Inc., and others since 2002.

Data from 2006 shows, the agency took about 335 days, on average, to approve new devices, ranging from syringes to x-ray machines, in comparison to 438 says in 2005.

Approval of medical devices that fall under the agency's separate, "510k" application required an average of 95 days in 2006, compared to 87 days in 2005.

The FDA estimates they cleared 2,640 devices for use under the "510k" process in 2007, compared to 2,677 devices during 2006.

Typically, the average FDA review time from request to decision has decreased since Congress passed a law revamping medical device regulations in 2002.

2007 approval data is not yet available.