The Successful 510(k)

5000+ 510(k)s Every Year to FDA
Clearly getting 510(k) approval is the primary way that medical devices get to market in the States. But the 510(k) is no longer considered a simple premarket notification, but rather a junior premarket clearance, and requires careful thought and planning to be successful. And there are five categories to consider: 1) de novo, 2) traditional, 3) abbreviated, 4) special, and 5) no 510(k) needed.   

The e Conference:
Janice Hogan and Yarmela Pavlovic will speak to us about the circumstances which require a 510(k) submission, criteria for establishing substantial equivalence, how to choose which type of 510(k) and how to choose a predicate device and the contents of a 510(k). They will guide us in structuring an application to present the best argument, contrast testing data versus descriptive data, and discuss the use of clinical data.

This fourth course in a 4-part series:
June 25: An Introduction to FDA....
July 30: Regulatory Submission Plans
Aug 20: The Successful IDE
Sep 24: The Successful 510k

You will receive:
1. A foundation to build on.
2. Clarity about your options.
3. PowerPoint slides.
4. An expert speaker.
5. Case studies and examples.
6. Chance for QnA.
7. CEUs and certification of attendance

The presenters:
Janice Hogan is a partner in the offices of Hogan and Hartson LLP and a member of the firm’s Food, Drug, Devices, and Agriculture Group. Her practice focuses on the representation of medical device [and other] manufacturers before FDA. She is a biomedical engineer and specializes in regulatory counseling related to high technology medical products. You can reach Ms. Hogan at http://www.hhlaw.com/jmhogan/

Yarmela Pavlovic is an associate at Hogan & Hartson who works with medical device manufacturers to develop regulatory strategies for obtaining FDA marketing approval for their devices. She can be reached at http://www.hhlaw.com/ypavlovic/

Audience suitability:
[x] Regulatory professionals.
[x] Clinical research professionals whose trials will be used to support 510(k)s.
[x] Managers who sign off on clinical device trials.
[x] Managers who sign off on regulatory submissions.
[x] Executives who are planning their companies futures.

The purchase is $449 for OnDemand access and $499 for the CD. Event materials are available by download for OnDemand or are on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.