MDCI’s own Rosina Robinson, RN, M.Ed., RAC, and Principal Consultant, will be presenting a webinar tomorrow through Thompson Interactive entitled “New Updates on the 510(k): The IOM Report.” This webinar touches on the subject of yesterday’s MDCI blog post discussing the IOM report’s recommendations that the current 510(k) process be scrapped in favor of an entirely new system for approving medical devices in the United States.
Rosina Robinson has been active in regulatory affairs and healthcare delivery for more than three decades, and in that time she has put together over 50 510(k)s as well as many PMA and PMA supplements across a wide range of different medical device product categories. Robinson will be bringing her unique insight to bear on the IOM report by focusing on several important questions and concepts, including:
- Providing an in-depth explanation of the debate surrounding the current 510(k) process and the changes that it has recently undergone.
- Taking a closer look at the IOM’s recommendations regarding the 510(k) process, and examining how they could affect individual companies and the medical device industry as a whole.
- Examining the potential impact of the IOM suggestions on legislative, regulatory, and administrative facets of current FDA policy.
- Providing an assessment of how the IOM report’s recommendations could influence future changes to the 510(k) process.
The webinar will take place tomorrow, August 24, 2011, at 2:00 pm ET/1:00 pm CT/12:00 pm MT/11:00 am PT. The webinar is 90 minutes long and can be accessed at the following URL: http://www.thompsoninteractive.com/site/offer.jsp?promo=00119475&priority=00295701252.
MDCI Blogging Team