All posts tagged premarket approval
CDRH Issues Draft Guidance on Substantial Equivalence Determinations
January 3, 2012 | No comments
The Center for Device and Radiological Health (CDRH) is the branch of the FDA responsible for managing premarket approval 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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FDA Extends Comment Period on 510(k) Guidance
November 14, 2011 | No comments
The FDA has extended the public comment period for its draft guidance on medical device 510(k) clearance for modified devices. …
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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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