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