Wednesday, January 12, 2011
510(k) Reform: Adapting to New FDA Standards and Changes
The FDA is preparing to announce planned 510(k) program reforms by the end of December 2010, as stated by CDRH Director Jeffrey Shuren on December 1. But major concerns remain: Will devices get cleared and approved at a faster pace? Will the FDA give the device industry what it wants – predictability, transparency and reasonable data requirements?
During this webinar, Mark DuVal, one of the leading attorneys and advocates for medical device makers, will discuss the current status of the 510(k) reform, new changes to the program, increasing Congressional commentary and what device makers need to prepare for in the months ahead.
In 90 minutes, you will discover:
- Industry is in “tweener” status: FDA’s internal Working Group and IOM recommendations are proposed, but not finalized
- FDA has brought on intense and increasingly loud Congressional commentary and oversight—who is speaking out?
- Is FDA listening, and where are we headed?
- How have the elections changed the complexion of things?
- What does this mean for the review of current 510(k) submissions?
Mark will also answer your team's questions in the Q&A session.
For one low price, you and your entire team from one location can take part in this fast-paced, insightful webinar. Best of all, you'll be able to connect personally with our panelists when we open up the phone lines for live Q&A.
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January 12, 2011  Add to Outlook Calendar
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