There has been a lot of news lately – both positive and negative – about the FDA’s 510(k) medical device clearance process. FDA, Congress, and many third parties are reviewing the process for efficiency and effectiveness. The FDA has hired many new reviewers, but training has been slow. They have released new guidance documents relating to 510(k) submission components, but they are radically different than the previous interpretation of the requirements.

The result of all this change has been that review times have increased by 65 percent since 2005, and the number of reject decisions – not substantially equivalent, NSE determinations – increased from a historic level of 3.5 percent to 8 percent of 510(k) submissions during the 2010 fiscal year.

This is the new normal. Even if you sent in a submission two years ago, it might not be acceptable now. So what exactly does FDA want to see in your 510(k) submission, and how do medical device manufacturers cope with this new reality?

This audio conference covers:

• An overview of the 510(k) process
• A review of the basic components of a submission
• The information requirement differences between certain submissions
• How to create a regulatory strategy and path
• A review of some of the new guidance documents that may affect submissions
• How to reduce the likelihood your submission will be rejected
• How to handle an FDA request for additional information

About the speaker:

F. David Rothkopf has over 20 years of professional strategic experience in the development and regulatory control of medical devices. He is the president and co-founding principal at MEDIcept, established in 1997 to offer quality, regulatory, engineering, and manufacturing consulting assistance to the medical device industry. David’s expertise includes technical and hands-on knowledge in a variety of regulatory, management, and quality processes. He has performed well over 300: ISO 13485 and FDA-style audits over the last 15 years. David has submitted over sixty 510ks and PMAs and with other MEDIcept personnel has developed almost 150 submissions. David has taught classes at the RAPS, ASQ, and SQA annual meetings. In addition to being president of MEDIcept Inc., David has been instrumental in starting three medical device companies and is a major equity holder and corporate advisor for four others. He holds both a Bachelor and Master of Mechanical Engineering degree from WPI in Massachusetts and an MBA from Boston University.

Who should attend?

• Regulatory Affairs
• R&D
• Engineering
• Legal Counsel