The FDA's Amendment's Act of 2007

Why take this eConference?
FDA is transforming its operations because the world of medical technology is getting more complex, the old ways can't keep pace with the new challenges, and there needs to be a better way to integrate premarket and post-market processes.--D-B Tillman, Director, ODE/CDRH; 2007.

Objective:
To provide participants with an update on FDAAA, focusing on practical consequences for device companies.

Who should attend:
Regulatory and clinical professionals who will be affected by the new law and its requirements.

You will learn:
All key elements of the new law, including what steps should be taken to ensure compliance, including:

- Reauthorization of medical device user fees through Fiscal Year 2012;
- Changes to FDA performance goals for medical device submissions;
- Modification of the Establishment Registration and Device Listing Program;
- Modification of the Clinical Trials Registry to apply to certain medical device trials;
- Changes related to pediatric devices;
- Authorization of the establishment of a unique identifier system for medical devices; and
- Allocation of funding to FDA for postmarket surveillance of medical devices.

You will receive:
- Slides
- An expert speaker
- A chance to listen to other's Q&A
- CEUs & Certificate

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/

The purchase is $403 for the CD. Event materials are available 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.