FDA Schedules Public Meeting on Premarket Clearance Process for Medical Devices

FDA through a new release on Jan 22nd 2010 announced that it has scheduled a public meeting on Feb. 18th 2010, to discuss key issues and challenges related to the premarket notification, or the 510(k) process. This meeting will complement the ongoing comprehensive study, which was initiated on FDA request, by the Institute of Medicine on the process of the 510(k).

FDA receives more than 3000 510(k) submission each year. 510(k) process is different from the Premarket Approval Process (PMA) which requires extensive clinical studies. PMA’s are required for class III devices which are generally considered as a ‘high risk’ device and hence are highly regulated. Some of the examples of devices requiring a PMA are pace makers and heart valves for human use. Whereas 510(k) is required for most class II and some class I devices and as a part of this process the device maker must prove substantial equivalence to a legally marketed device (Predicate device).

510(k) was established by the FDA under Medical Device Amendment Act with the following objectives:

1. Make safe and effective devices available to consumers; and
2. Promote innovation in the medical device industry.

Technological advances and the changes in the medical device industry have made the FDA review its 510(k) process. The Feb. 18 meeting, slated for 8 a.m. to 5:30 p.m. in Gaithersburg, Md. will focus on the following challenges faced by the FDA with regards to the 510(k) process:

• issues related to predicate devices, which are previously cleared devices that may support a manufacturer’s claim of substantial equivalence.
• issues related to new technologies and scientific evidence
• issues related to practices the FDA has adopted in response to a high volume of submissions
• issues related to postmarketing surveillance and new information about marketed devices.

There would be a presentation by the FDA on the above discussed issues and this will be followed by an open comment sessions. For information on Venue and the registration process please follow the link to the FDA news release http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198479.htm

To discuss how the outcomes of this meeting could affect your business, e-mail us at info@mdiconsultants.com  and reference “510(k) meeting”.

If you have any comments, please contact us at info@mdiconsultants.com