On Oct 4, 2010 the Federal Register published the “Modifications to the List of Recognized Standards, Recognition List Number: 025“. This list will assist medical device manufacturers who elect to declare conformity with FDA Consensus Standards to meet certain FDA
Stricter 510(k) Process Offers Challenges, Promises
From MDDI Magazine – Sept 2010 – “FDA has released its long-awaited plans to shore up the 510(k) clearance system used to get many medical devices to market. In August, the agency published a 120-page report to define which devices
How Comment on FDA CDRH FY11 Draft Guidance Documents?
How to comment on FDA CDRH FY11 Draft Guidance Documents?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 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
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