Tag Archives: CDRH
FDA’s Shuren on Tightening Future FDA Review of High-Risk Devices
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 Shuren has headed the Center for Devices and Radiological Health [continue reading…]
FDA Workshop on Health of Women
April 9, 2013 ~ According to a new page on the FDA’s website (here), a public workshop will be held on HoW to Improve the Health of Women (HoW). The purpose is to delve into how some medical devices work differently in women than men. It’s been noted that some hip implants have an [continue reading…]
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 FDA who claim they [continue reading…]
FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient
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 prominent warning that would have told them what they were [continue reading…]
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 and retaliation against whistleblowers should never [continue reading…]
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 Obama was taking office [continue reading…]
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 whether the product is a breast [continue reading…]
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, defective medical devices that [continue reading…]
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 that could speed up product reviews [continue reading…]
Former FDA Director Joins Consulting Company as President, Market Watch, September 14
Is this the revolving door? Ron Johnson, former Director of the Office of Compliance within the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), has taken a job as President of BECKER CONSULTING, according to a press release on Market Watch. According to the release, Mr. Johnson [continue reading…]
