510(k) Process Changes Survival Guide Practical Answers in 90 Minutes
Product Details
On Dec. 27, 2011, the FDA gave the industry a belated holiday gift: A series of guidances intended to put to rest the controversy regarding 510(k)-related clearances. But has it succeeded?
The jury is still out. Many are still wondering about that footnote that appears to have scraped the use of “split predicates.” And is it possible to defy long-held beliefs and use more than 5 predicates?
What about the six-step flowchart the FDA is going to employ? A “no” on any one of 4 out of 6 steps will get your device ruled not substantially equivalent. Are you prepared?
As these changes take hold, the impact on how the industry does business will be substantial.
To assess that impact, FDAnews has assembled three regulatory experts from one of the nation's top FDA law firms for a 90-minute audio CD/transcript on the state of the 510(k) process.
In this comprehensive presentation, you'll get clear-headed guidance on a variety of topics, including:
- The background behind the FDA's decision to modify the 510(k) process
- Identifying the FDA's goals for the process
- The progress it has made in 2011 and 2012 to implement these changes
- A discussion of the changes planned for 2012 and beyond
- The legal implications for a new guidance flowchart and the sample risk analysis summaries
- Potential impact of the draft guidance
- And more
Meet Your Instructors
Neil O'Flaherty, a principal at Olsson Frank Weeda Terman Matz PC (OFW Law), focuses his practice on FDA regulation of medical devices and other FDA-regulated products. He has lectured both in the U.S. and abroad on FDA-related topics, and has provided assistance to the Advanced Medical Technology Association, the nation's largest trade association for the medical device industry.
Evan Phelps, a principal at OFW Law, advises companies on FDA and DEA compliance, focusing on matters related to medical devices and biologics as well as those affecting clinical investigators. Prior to joining the firm, he conducted multiple counter-narcotic operations in South and Central America during his tenure as a U.S. Army Officer.
Nancy Mathewson, an associate at OFW Law, practices FDA regulation and international product registration law. Drawing on her extensive industry experience at medical device and pharmaceutical companies, she is well-versed in issues involving regulatory affairs, quality assurance and medical device product development.