Eisner Safety Consultants Website http://ht.ly/2zeE0 back up & safe to use again … Got hit by a malware attack.
CDRH Webinar re: 2 rprts: #510(k) proc & use of Sci in decision making process
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
EU RAPEX – System for dangerous consumer goods…
Europa EU Rapid Alert System non-food consumer products (RAPEX): Doesn’t include medical devices, pharmaceuticals, and food http://ht.ly/2twrt Source Europa Webpage http://ht.ly/2twrt for the following information on RAPEX: RAPEX is the EU rapid alert system for dangerous consumer products – with the
Just Say No to FDA’s Idea of Transparency? MD&DI
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
Device Industry Critic to Join CDRH as 1st Deputy Dir of Science?
Device Industry Critic to Join CDRH as first Deputy Director of Science? – From Medical Device Summit http://ht.ly/2s5c0
