Eisner Safety Consultants

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

FDA Issues Assessments of 510(k) Process & Use of Science in Decision-Making http://ht.ly/2mcXz

FDA 510(k) Process Under the Microscope: How Will Changes Impact You? – Newport Beach, Ca 7/29/10 CA Healthcare Institute http://ht.ly/2fbvs

Draft FDA Guidance – Infusion Pumps – Total Product Life Cycle – Premarket Notification [510(k)] Submissions http://ow.ly/1EjNL