Eisner Safety Consultants

Below is a copy from the FDA webpage on Innovation Pathway. Innovation Pathway Background on CDRH Innovation On Feb. 8, 2011, the FDA’s Center for Devices and Radiological Health launched its Innovation Initiative, which proposed actions the agency could take to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical [...]

There will be an FDA Town Hall meeting on March 10, 2011 with the Director of CDRH and with other top management of the CDRH.  The meeting will be held at the Irving Convention Center at Las Colinas, 500 West Las Colinas Blvd., Irving, TX.  The meeting will not be videotaped or webcast and will [...]

How to comment on FDA CDRH FY11 Draft Guidance Documents? http://ht.ly/2OiXg From the FDA CDRH webpage titled “Documents the CDRH is Considering for Development (FY11)” the following is the intoduction to the page: “This is the list of guidance documents CDRH is considering for development this year (2011). CDRH plans to update this list every [...]

CDRH Webinar to discuss 2 reports: 510(k) premarket review process and the use of science in CDRH’s regulatory decision making process to respond to questions & concerns will be on 31-Aug-10 http://ht.ly/2vNw7

Just Say No to FDA’s Idea of Transparency from MD&DI Magazine Aug-10 http://ht.ly/2sa6c See our post FDA Issue Assessment of 510(k) for the FDA assessment report on the 510(k) process