All posts tagged CDRH
Report: Internal FDA Reports Slams European Regulation of Medical Devices as Ineffective
April 24, 2012 | 2 comments
The FDA has criticized Europe’s review process for medical devices in an unreleased internal report, claiming the failure of some …
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New FDA Guidance on Considerations Used in Device Approval, De Novo Decisions
March 28, 2012 | No comments
The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of …
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FDA Offers New Guidance for Artificial Pancreas Device Systems
December 1, 2011 | No comments
The FDA issued new guidelines on Thursday for the development of a potentially revolutionary device to treat type 1 diabetes …
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Six Mistakes That Will Delay Your FDA 510k Submission
October 31, 2011 | No comments
In July 2011, the FDA conducted an analysis of its 510(k) data to determine the causes of increasing medical device …
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Mobile Medical Apps
October 26, 2011 | No comments
The FDA issued draft guidelines on mobile medical apps. Developers will likely complain that the FDA guidelines will make it …
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FDA Announces New Staff Training for Medical Device Reviewers
September 6, 2011 | No comments
The FDA announced today two new training programs designed to improve the consistency of medical device reviews by enhancing the …
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