Regulatory Updates

1. FDA Changes Process for Medical Device Advisory Committees
April 26, 2010 the FDA announced that it will change the way its expert panels review and discuss data and information during public hearings on medical devices under review for premarket approval. the panel will vote on the safety and effectiveness of a device and the device’s risk versus its benefit. Also the panels will vote using ballot instead of by a show of hands. These changes are going to be effective May 1, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209791.htm

2. FDA recently announced a Medical Device Use in the Home Environment Workshop: Implications for the Safe and Effective Use of Medical Device Technology Migrating into the Home. The main purpose of the workshop to gather information from health care providers, academia, human factors experts, industry, medical device distributors, manufacturers, professional societies, patient advocate groups and patients on the issues and challenges with using medical device technology at home. The workshop will be held on May 24, 2010 at the Hilton in Silver Spring, MD.
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm205804.htm

3. May 3, 2010 the Board of Directors of the Biotechnology Industry Organization (BIO) elected a new group of officers and nine new board members at BIO’s 2010 International Convention.
http://www.bio.org/news/pressreleases/newsitem.asp?id=2010_0503_02