All posts tagged Center for Devices and Radiological Health (CDRH)
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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Medical Device Pre-Market Programs: An Overview of FDA Actions
October 20, 2011 | No comments
Nearly two years ago, the FDA’s Center for Devices and Radiological Health (CDRH) recognized the need to re-evaluate and modernize …
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Medical Devices Get Parallel Review Pilot From FDA and CMS
October 11, 2011 | No comments
Those creating medical devices often discover after putting all their energy into getting FDA approval that Medicare coverage doesn’t automatically …
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Deciding When to Submit a 510(k) for a Change to an Existing Device
October 10, 2011 | No comments
I am currently working with a client on a Special 510(k). This is an application to modify the 510(k) on …
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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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