How to comment on FDA CDRH FY11 Draft Guidance Documents?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
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Have you signed up for our newsletters? Full of vital Medical Dvc Regulatory, Compliance, & Quality Systems info http://ht.ly/2Cs0V
Eisner Safety Consultants Website Up & Running Safely
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