Medical Development Group December 14 Forum: FDA and the 510(k) Process – What to Expect Now and Down the Road

Boston, MA, November 17, 2011 --(PR.com)-- The Medical Development Group announces its Wednesday, December 14, 2011 Forum entitled “FDA and the 510(k) process – What to expect now and down the road.” A 510(k), or premarket notification, is a submission made to the FDA to demonstrate that a new, moderate-risk device that has not yet been marketed is “substantially equivalent” to a legally-marketed device. This process is to allow the FDA to make a risk-based assessment of new or modified products before permitting them on the market.

In recent years, FDA’s CDRH has often asked for additional evidence to support a 510(k) (including clinical studies) when questions arise about a new device’s safety or effectiveness. Patient advocacy groups and other stakeholders have also questioned whether the 510(k) process adequately protects patients, leading to calls for reform.

Please join them to hear their expert panel address:

An overview of the current process
Tips for how to most effectively work with the FDA CDRH
Hot Topics and Proposed Reforms for this process

You’ll hear first-hand experiences with the FDA 510(k) process, learn ways to address this complex, yet integral practice to market medical devices in the US, and to understand the current reform proposals being considered and debated.

Who Should Attend:

Individuals in the MDG community who want to better understand the needs and challenges that arise in the FDA 510(k) process.

Companies and people in the MDG community interested in addressing their FDA 510(k) submissions more quickly and in a more cost effective manner.

Companies and people in the MDG community interested in better understanding the current and potential future changes in FDA 510(k) submission requirements.

Moderator: David R. Pierson, Partner, Foley Hoag LLP
Panelist: Barry Sands, President, RQMIS Inc.
Panelist: James M. Flaherty, Jr., Associate, Foley Hoag
Panelist: (FDA Speaker requested)

Link to event details: MDG Wednesday, December 14, 2011 Forum begins 5:30pm:

http://www.meddevgroup.org/

Registration Fee: Members: $25 (prepaid), $35 at the door.

Nonmembers: $35 (prepaid); $45 at the door. Cutoff for preregistration is 8 PM the evening before the event.

Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham, Massachusetts 02451-1436. See event link for directions: http://www.meddevgroup.org/.

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