CDRH

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FDA Pilot Program Helps Manufacturers Streamline Approval of Medical Devices

Mesh Medical Device News Desk, September 18, 2017 ~ The FDA spends much of its resources working with device and drug manufacturers to help ease their way to market. Here is another example of a newly announced pilot program that will help do just that.  Unlike drugs, high-risk medical devices, Read more

By | 2017-09-18T00:24:03+00:00 September 18th, 2017|FDA News|5 Comments

FDA’s Shuren on Tightening Future FDA Review of High-Risk Devices

Dr. Jeffrey Shuren, CDRH Mesh Medical Device News Desk, April 20, 2017 ~ FDA’s Jeff Shuren writes about how to serve two masters, public safety and the need of manufacturers for fast access to the marketplace for high-risk devices. Can anyone serve two masters? For seven years, Dr. Jeffrey Read more

By | 2017-04-20T10:36:33+00:00 April 20th, 2017|FDA News|4 Comments

FDA Whistleblower Case Moving Ahead

November 13, 2012 ~Round one in the FDA whistleblower scandal goes to the U.S. Food and Drug Administration. Regulatory Focus (here) reports the FDA had a minor victory November 9, in its case against the National Whistleblower Center (NWC) which is representing five both current and former employees of the Read more

By | 2012-11-13T22:43:22+00:00 November 13th, 2012|FDA News|1 Comment

FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

Dr. Jeffrey Shuren, CDRH If you ask the public, most say they want safer medical devices, not more of them.  If you ask the patients profiled in Mesh Device News Desk (MDND) they’d say they wished they’d known that the medical devices they received had come with a Read more

By | 2012-06-14T15:58:11+00:00 June 14th, 2012|FDA News|1 Comment

Sen. Grassley Comes to Defense of One Whistleblower in Letter to Hamburg

February 9, 2012 ~ “Whistleblowers point out fraud, waste and abuse when no one else will, and while they do so while risking their professional careers, they are often treated like skunks at a picnic,” Grassley wrote. “Whistleblowers have played a critical role in exposing harmful government actions Read more

By | 2012-02-08T15:50:07+00:00 February 8th, 2012|Featured|0 Comments

FDA Whistleblowers Sue Agency, Claim Retaliation Over Unsafe Medical Device Revelations

January 30, 2012 ~ What’s going on inside the FDA? Six of the “FDA Nine” whistleblowers are suing the agency for illegally spying on their private email claiming they were retaliated against after they warned lawmakers that unsafe medical devices were being approved for market.  You may recall as President Read more

By | 2012-01-30T23:38:33+00:00 January 30th, 2012|Featured|5 Comments

Toys from China and Medical Devices Share Scrutiny in EU

Many in the United Kingdom assume that an implanted medical device is reviewed for safety before it is permanently placed inside a patient. They would be wrong. The Guardian reports (here) that the European quality standard – the CE mark – represents an assurance that is the same Read more

By | 2012-01-27T21:25:23+00:00 January 27th, 2012|Media Reports|0 Comments

FDA: Medical Device Complications Growing Faster than Industry

Understanding Barriers to Medical Device Quality is the name of an FDA report issued October 31 by the Center for Devices and Radiological Health (CDRH) and the Food and Drug Administration (FDA) in an attempt to get a handle on why the medical device industry is putting out poorly made, Read more

By | 2011-11-08T03:55:31+00:00 November 8th, 2011|FDA News|0 Comments

How to Speed Up Approval of Medical Devices?

OCTOBER 3, 2011 -  How to speed up the approval of a medical device that cannot claim it is substantially similar to one already on the market under 510(k)? On Friday, September 30, the Food and Drug Administration released a long-awaited proposed revision to the 510(k) clearance process Read more

By | 2011-10-04T03:01:12+00:00 October 4th, 2011|FDA News|0 Comments