Thursday, July 29, 2010

What the New 510(k) Will Mean for You

This is the second of Mark DuVal's insightful presentations on changes coming to the 510(k) program. For a CD and transcript of Part 1, please click here.

You know the 510(k) program will soon change—but how? And more importantly, how will those changes affect you and your business?

Mark DuVal and the Minnesota Medical Device Alliance (MMDA) have spoken in-depth with CDRH Director Dr. Jeffrey Shuren and other Center representatives on the coming changes to the 510(k) program.
And in this 90 minute webinar, he will share the insight he has gained, including:

What the future holds for de novo 510(k) classification—does CDRH intend to limit or remove de novo entirely?
What level of evidence will be required? New testing requirements or clinical trial requirements? Post-market surveillance?
When will a PMA make more sense than a 510(k)?
When can you expect all these changes to take place? And how will the 510(k) program likely change in the next 90 days, six months, and one year?
How might the third party 510(k) review program change?

Mark will also update you on changes to the issues he discussed in Part 1 of this webinar series, including:

If the Agency will make it easier to rescind 510(k) clearance
Changes the internal CDRH 510(k) Working Group is considering
The changes that are coming to substantial equivalence (new indications, new technological characteristics, how many predicate devices, etc.) and other standards integral to the 510(k) pathway.
Reporting of incremental changes made to cleared devices

Mark will also answer your team's questions in the Q&A session.

Who should attend...

Medical Device Compliance and regulatory affairs professionals
Medical Device General, corporate, outside counsel
Medical Device executives
Anyone dealing with 510(k), PMA, or other device submissions
Anyone responsible for device pre-market studies or post-market surveillance

For one low price, you and your entire team from one location can take part in this fast-paced, insightful webinar. Best of all, you'll be able to connect personally with our panelists when we open up the phone lines for live Q & A.

SPEAKERS

Mark DuVal
President
DuVal & Associates, P.A.

Mark's practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA, clinical trial negotiations and more.

Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.

Mark earned his J.D. with honors from the William Mitchell College of Law. He is a frequent speaker and author of articles and papers addressing FDA topics.

Webinar Details

DATE: Thursday, July 29, 2010
TIME: 1:00 PM ET • 11:00 AM MT • 10:00 AM PT
DURATION: 90 Minutes

Benefits

What does registration get me?

One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
One (1) password to a website on which you'll be taken through the presenters' slides as they speak to them.
An interactive Q&A round with speakers by phone and electronic submission.
The insight you've come to expect and respect from Elsevier Business Intelligence and our guest speakers.

What are the unique benefits of a webinar?

Convenience—and lower cost. Your entire team can listen in one room. No travel required!
A team approach. You've often wanted to have everyone on your team getting the same knowledge and insight you derive from physical conferences. Now you can.
Interactivity. You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference.
Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time

SUPPORTING PUBLICATIONS

REGISTRATION

Buy the recording/transcript: Click here for just the recorded webinar with the complete transcript, $349
Register by email: custcare@elsevier.com
Register by phone: 1 (800) 332-2181(U.S.) / +1 (908) 547-2159 (non- U.S.)

Webinar Cancellation Policy: No refunds or credits will be given one week prior to the scheduled webinar, or after the webinar presentation materials and access instructions have been sent to participants. In lieu of cancellation, you may substitute another delegate from your company as a replacement.