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Medical Device Breakfast Series How the FDA’s 510(k) Programs Are Changing

Medical device start-ups face intense competition for a finite amount of available capital funding. With fears growing among investors that 510(k) clearances are no longer as quick, easy and inexpensive as they used to be, funding for companies hoping to enter the market via 510(k) is drying up. Many of them are no longer seen as a guaranteed low-risk investment. How real are these concerns? How is the FDA’s 510(k) program changing? What are the real-life experiences of companies that have recently used the process? A panel of regulatory and business experts will share their up-to-date knowledge, so you can decide for yourself whether your 510(k) strategy is still viable or in need or re-evaluation.

Moderator

Michael A. Swit, Esq.
Vice President, The Weinberg Group Inc.

Panel Speakers

Janice E Brown, RAC
Director, Regulatory Affairs Boston Scientific Corporation

Timothy R. Placek
Vice President, Regulatory Affairs & Quality Systems, Spinal Modulation

What: Medical Device Breakfast Series
How the FDA’s 510(k) Programs Are Changing
When: May 11, 2010
8:00 – 10:00am
Where: Cooley Godward Kronish LLP
Palo Alto Campus
3175 Hanover Street
Palo Alto, CA 94304
Directions
Parking: Free parking
Attire: Business attire suggested
Cost: Early Bird Registration through May 9:
$10.00 – BayBio & MDMA Members, Bio2Device and Bio-X Affiliates
$20.00 – Non-Members

On-Site Registration, May 11:
$20.00 – BayBio & MDMA Members, Bio2Device and Bio-X Affiliates
$40.00 – Non-Members