The FDA and Medical Device Regulation
How the Changes Underway Impact Your Business

Sponsored by:

Overview:
The FDA medical device regulation process has been under review by Congress and by FDA. Legislation is under consideration that may change the way in which submissions are prepared. The 510(k) process and the use of substantial equivalents is being questioned and this may lead to a change in review and approval process for new medical devices.  These changes will affect manufacturers of medical devices. The time to market, the length of the approval process and ultimately the cost of bringing a new medical device to market will be affected.

This breakfast seminar will give the medical device manufacturer, regulatory professional and marketing specialist information on the potential changes, their timing and the motivating elements that are moving the adoption of these changes forward.

Areas Covered in the Seminar:

• Legislative actions that are motivating change to the medical device regulatory submission and approval process
• The timing of such changes
• The potential impact on the approval of new medical devices by FDA
• Pre-market approval changes and its impact on medical device manufacturers
• What you will need to consider as your company adjusts to a new regulatory environment

Who Should Attend:

• Regulatory Professionals specializing in medical devices
• C-level and management level persons from medical device companies
• Lawyers involved with medical device companies and FDA compliance issues
• Product and Sales Managers employed by medical device manufacturers

Keynote Speaker:

Mark Leahey,  President & CEO
Medical Device Manufacturers Association (MDMA)

Moderator:

Robert Kerwin,  Member
Tarlow, Breed, Hart & Rodgers PC

Panelists:

Glen Emelock, Senior Partner
The CRO Group, Inc.

Annette Vaughan, Principal
Stonebridge Associates

Wayne Webster, President
Proactics Consulting

Agenda:

7:30-8:00am Breakfast and Networking
8:00-8:45am Keynote presentation by Mark Leahey, President MDMA

• Regulatory and Legislative Initiatives Under Consideration

8:45-9:30am Panel discussion and Q&A - concerning a variety of topics including but not limited to

• the timing of changes
• pre-market approval challenges
• bringing product to market
• where the money seems to be flowing

 

Admission:
MVVF, MDG Members and Affiliates  $20
Non-Members $40

Register at this link