FDA Public Meeting
FDA Public Meeting - Incorporation of New Science into Regulatory Decision Making within CDRH
Written by: Rosina RobinsonWednesday, February 17th, 2010 | FDA Medical Device Regulations | No Comments
The FDA Public Meeting, “Incorporation of New Science into Regulatory Decision making within the Center for Devices and Radiological Health,” was held on February 9, 2010 despite challenging weather conditions in the Washington, DC metropolitan area, both before and after the meeting.
The weather conditions caused the meeting schedule to be compressed by nearly 30% to accommodate rapid cancellation of transportation options, and resulted in sparse attendance at what FDA expected to be a “sold out” event. Despite the challenges, meeting participants aggressively addressed all four pre-defined case studies on the agenda, including accommodating probing questions by Agency staffers. › Continue reading
Subscribe via Email
Search
Contributors
Categories
Archives
Recent Posts
- FDA Publishes Rule to Require PMA or PDP for Four Class III Preamendment Devices
- Industry Slow to Respond to FDA Call for Infusion Pump Assurance Case Reports and Clinical Evaluations
- FDA Update - CDRH Issues Medical Device Recommendations
- Q1 Conference in Baltimore Highlights FDA Regulatory Challenges for Combination Products
- FDA Could Tighten Focus on Human Factors Testing for Medical Devices