The Successful 510(k) - June, 2007

This eConference is the Third in a Four-Part Series on medical device regulations. The series consists of:

1. Part 1-Part 812
2. Part 2-The Successful IDE
3. Part 3-The Successful 510k
4. Part 4-The Successful PMA

Objective:
To inform less experienced regulatory affairs professionals about the overall requirements associated with 510(k) submissions and to inform or remind the more experienced professionals of the best ways to deal with difficult applications.  

 

You will learn:

• The circumstances which require a 510(k) submission
• The criteria for establishing substantial equivalence
• The types of 510(k)s that are available 
• How to choose the best predicate device
• What a 510(k) must contain
• How to structure an application to present the best argument
• The role of testing data versus descriptive data
• The use of clinical data      

You will receive:

• A foundation to build on
• Knowledge about how to choose a predicate
• Clarity about your options
• Insight in dealing with problems
• A chance to ask questions and get answers
• An experienced speaker
• Certificate and CEUs

Who should attend:
This eConference is designed for regulatory affairs specialists who prepare 510(k)s and clinical affairs specialist who wish to understand more about a process to which they often contribute.  

 

Presenter:
Clinical Device Group is proud to present Ms. Janice M. Hogan, Esq. and Partner of  Hogan & Hartson, LLP. Janice is a biomedical engineer and focuses on regulatory counseling related to high technology medical products. Prior to becoming an attorney, she held positions in marketing/ marketing research for a major pharmaceutical manufacturer. She has authored articles regarding orphan drug regulation and medical device products liability. She is currently authoring articles regarding the use of finite element analysis and other engineering modeling methods in FDA submissions, as well as the interface between FDA regulatory and reimbursement considerations in the design of medical product clinical trials. She has authored a chapter of a recent textbook, Promotion of Biomedical Products (FDLI 2006) and is authoring a chapter of a forthcoming textbook on the regulation of orthopedic implants. Janice has served as an adjunct professor at the University of the Sciences in Philadelphia and as a guest lecturer at Drexel University. She is also a frequent lecturer at FDA regulatory law symposia and conferences on topics related to premarket approval of medical products, combination products regulation, and product development. Janice can be reached at http://www.hhlaw.com/jmhogan/

 

The purchase is $408 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.