FDAs Changes to the 510(k) Process: Are You Prepared?
Venue: Your Office
|Event Date/Time: Sep 30, 2010|
With expected changes in the usage of 510(k) definitions and, more broadly, in the operation of the program, it is essential that those in the medical device industry begin to prepare now to ensure future compliance.
In this 90-minute audio conference, attorneys James Ravitz and Naomi Halpern of Arent Fox LLP will explain what you need to know about the FDAâ€™s recommendations for the 510(k) process. Mr. Ravitz and Ms. Halpern will also describe what steps you can take to begin planning for the upcoming changes.
* What are the key changes that have been proposed?
* How will the expected changes affect device makers?
o What additional costs might device makers face in light of new regulatory requirements?
o What will the proposed changes mean for the number of devices cleared?
* What do the proposed changes mean for the definition of â€œsubstantial equivalence to a predicateâ€?
* How will the proposed changes affect so-called â€œsplit-predicatesâ€?
* What is the regulatory process for implementing the recommendations?
* What can device companies do to prepare for upcoming changes?
Attendees Who Will Benefit From This Audio Conference Include:
* ANYONE involved in 510(k) submissions
* Medical device compliance professionals
* General counsel
* Corporate counsel
* Corporate directors and executives