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At Fda A New Goal Then A Push For Speedy Device Reviews - Latest News


At FDA, a new goal, then a push for speedy device reviews

WASHINGTON (AP) — Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices. "We don't use our people as guinea pigs in the U.S.," Shuren ... read more

FDA’s push for speedy device reviews raises questions

Under Shuren, annual new device approvals ... Lurie said, the FDA has opened the door to lowering its own standards to achieve its goal. The FDA’s struggle to find the right mix of regulation and ... read more

Has FDA’s ‘First In The World’ Ambition Contributed To Years Of High-Profile Safety Problems With Medical Devices?

The Associated Press: At FDA, A New Goal, Then A Push For Speedy Device Reviews Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices. ... read more

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FDA's 'flawed' device pathway persists with industry backing

The FDA's move came one day after the publication of a global investigation into medical device safety by more than 50 media ... adding that streamlined reviews are generally reserved for lower-risk ... read more


FDA comes under fire for rapid Apple Watch approvals

The Food and Drug Administration’s quick approval of new mobile medical apps designed ... a result typically take longer to approve than a follow-on device cleared through the 510(k) process. “FDA’s ... read more

CDRH Revamps 510(k) Clearances With ‘Safety and Performance Based Pathway’

A US Food and Drug Administration (FDA) final guidance sets the stage for how the agency intends to make the voluntary option for 510(k) clearance the main pathway for medical device regulatory ... read more

Must-Reads Of The Week From Brianna Labuskes

The Associated Press: At FDA, a New Goal, Then a Push for Speedy Device Reviews In the miscellaneous file this week: • The combined suicide and opioid crises are taking a particularly grim toll on the ... read more

Lemon: Trump is showing how rattled he is

CNN's Don Lemon says President Trump fired Jeff Sessions, the former attorney general, and then held a 90-minute "temper tantrum" in the White House because he is rattled by the results of the 2018 ... read more

FDA Changes Will Reward Medical Device Innovation: Here’s What Investors Need to Know

NEW ... device industry to bring better products to market, it makes sense to look for true innovators in this space. The FDA Will Push for Device Makers to Innovate The FDA's 510(k) clearance pathway ... read more

FDA Goes All Out With Digital Health Regulatory Paradigm Shift

“Our goal will be to help modernize our framework ... These changes and the new guidance on device products containing multiple functions form part of FDA’s push—set in motion in 2017 with the Digital ... read more



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