FDA to Hold Public Meeting on the 510(k) process – Feb. 18.
RE: Strengthening the Center for Devices and Radiological Health's
510(k) Review Process; Public Meeting

It appears that someone in the government feels that the process has problems, from the use of predicates, device creep, high volume of submissions and the post market surveillance.

So, to see what comments the industry has concerning the 510(k) process the FDA has set up a public meeting. The public meeting will be held at the Hilton Washington DC North/ Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. A live webcast of this meeting will be viewable on the day of the meeting at http://www.ConnectLive.com/events/fda021810. Closed captioning for this webcast will be available at http://www.speche.com/sbload.aspx?Load=Web.

The four separates to be covered are:

A. Issues related to predicate devices,
B. Issues related to new technologies and scientific evidence,
C. Issues related to practices CDRH has adopted in response to a high volume of 510(k) submissions,
D. Issues related to post market surveillance and new information about marketed devices.

The FDA is allowing speakers at each panel. So if you are interested in making a presentation on the 510(k) experiences you have been having you can go to the FDA link and submit a request to present.

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm

For more information on this FDA meeting please contact us at info@mdiconsultants.com and ref : 510(k) public meeting.