Many companies make subtle changes to their devices over time. However, those subtle changes can add up to the point where the current design no longer matches the product deemed safe and effective by the FDA. Whether you just received clearance for your product or it was last cleared in the last century, the FDA has stepped up enforcement on modifications to devices without notification. During site investigations, the FDA is looking at design changes and reviewing all the changes between now and when you last received a 510(k) clearance.

In July 2011 the FDA released a draft guidance document on 510(k) device modification and when to submit a new 510(k) for an existing device. This document reflects the current thinking of the FDA, and will replace the present guidance released in 1997. Are you ready? Do you know the configuration of your product when it was last cleared? Those “letter to file” changes might no longer be acceptable. This audio conference presentation reviews the new guidance document, looks at how to perform a design gap analysis on a device, and discusses what to do when you realize you probably should submit a new 510(k).

This audio conference covers:

• FDA's new draft guidance on 510(k) device modification
• What FDA is looking for in site investigations
• Gap analysis - determining whether your device might need a new 510(k)
• How to proceed if it does

About the speaker:

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