Interacting and Avoiding Problems with FDA

A free live telephone seminar presented by:

Wednesday, February 25, 2009

1:00 p.m. - 2:30 p.m. EST

12:00 p.m. - 1:30 p.m. CST

11:00 a.m - 12:30 p.m MST

10:00 a.m. - 11:30 a.m. PST

Most device firms intend to comply with FDA's requirements. However, best intentions are often not enough. Device companies can unwittingly implement policies or fall into practices that undercut their best intentions and, as a result, create FDA compliance issues for the company. Many FDA regulatory issues require effective fact finding, discussion, negotiation, and resolution with FDA. To thrive in the FDA regulatory environment, it is critical for companies and individuals to know where the common pitfalls are, how to avoid them, and how best to deal with FDA.

OFW proudly presents the first in a continuing series of telephone seminars. This first seminar will cover how to avoid common mistakes made by medical device companies and how to interact effectively with FDA. It is a "must attend" educational seminar for those persons charged with ensuring the regulatory compliance of medical device companies, such as regulatory professionals, or personnel in the legal departments of these companies.

Your presenters will be Stephen D. Terman and Neil F. O'Flaherty, principals in the Medical Device Practice Group at OFW Law. Steve and Neil specialize in U.S. FDA regulation of medical devices and regularly deal with medical device regulatory issues for their clients. They will draw upon their combined 50 years of FDA experience at the FDA, and AdvaMed (formerly HIMA) and in private practice, to provide you with helpful information you need to know to protect your company.

Registration closes at 2:00 p.m. on February 23, 2009. Space is limited and early registration is suggested to reserve your opportunity to participate in this seminar.

If you have any questions, please contact us at MedicalDevice@ofwlaw.com.