Choosing a Regulatory Submission Plan

Cheapest Claims First?
I've often advised clients to make a list of all the possible assertions of truth they want to make about their device and determine the cost, schedule and regulatory requirements for each of them. Working from a matrix, if financing is an issue, go for the cheapest claim first; if timing is the issue, go for the fastest claim first, but if you have the luxury of time and money, go for the claim that blocks your competition.

Janice Hogan will speak about how to decide if you want a PMA or a 510K, which kind of 510k (there are four), a class II device or a Class III device, and the business advantages and disadvantages of each choice. If you didn't think you had a choice, well it's all in the claims. What you say about about your technology will often dictate the regulatory strategy and submission requirements.

This second course in a 4-part series:
An Introduction to FDA....
Regulatory Submission Plans
The Successful IDE
The Successful 510k

You will receive:
1. PowerPoint slides.
2. An expert speaker.
3. Case studies and examples.
4. Chance to listen to other's QnA.
5. CEUs and certification of attendance

The presenter:
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/

Audience suitability:
[x] Regulatory professionals.
[x] Clinical research professionals.
[x] People who work in clinical device trials.
[x] Marketing professionals.
[x] Monitors.
[x] Statistical professionals.
[x] Managers who sign off on clinical trials.
[x] Executives who are planning their companies futures.

The purchase is $422 for OnDemand access and $472 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.