Monday 19 February 2018

All posts tagged CDRH

Shutdown Delays Medical Device Approvals (510(k)s)

October 4, 2013 | No comments

As the shutdown continues the impact continues to be felt.  Some disruptions are expected, but given the broad and general […]

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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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