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March 5, 2019
FDA Commissioner Dr. Scott Gottlieb has handed in his resignation as head of the agency, according to a report in the Washington Post, which has been confirmed by HHS Secretary Alex Azar in a statement posted to his Twitter page as well as by Gottlieb himself later in the day. He will resign in one month.
"I’m immensely grateful for the opportunity to help lead this wonderful agency, for the...
February 6, 2019
The FDA released new draft guidance yesterday regarding premarket review for combination products — those with a mix of components that span across the agency’s drug, biologic and device product categories.
The proposed premarket guidance, which may still be adjusted based on public feedback, broadly advises industry to submit a single regulatory application within the pathway that most closely...
January 23, 2019
Looking to modernize the 510(k) process, yesterday the FDA announced its final guidance establishing the framework for the new Safety and Performance Based Pathway.
The biggest change to the 510(k) program is that instead of testing a new device in comparison to what is already on the market, new technology seeking clearance can be measured against a set of “objective, transparent and well...
April 30, 2018
At AcademyHealth’s 2018 Health Datapalooza on Thursday, the US Food and Drug Administration offered a vote of confidence for artificial intelligence in healthcare, promising more refined strategies for regulation, touting its tech incubator for AI innovation, and announcing a new machine learning partnership with Harvard.
"We’re implementing a new approach to the review of artificial intelligence...
December 21, 2017
Beyond fielding an ever-increasing number of digital health clearances, the FDA had a full plate in 2017 as it sought to revise its regulatory processes for the shifting healthcare landscape. The beginning of the year saw a new administration take the reins, and with it the nomination and appointment of a new commissioner, Dr. Scott Gottlieb. By the year’s end, the new guard already had announced...
July 27, 2017
The FDA is moving forward surprisingly quickly with its plan to create a pre-certification program for digital health app developers, originally announced in a blog post by new FDA Commissioner Dr. Scott Gottlieb last month. Now the agency has opened up applications for a nine-company pilot program to develop the program.
The basic goal of the Pre-Cert program, which sets it apart from previous...
June 15, 2017
Back in March, when President Donald Trump chose Dr. Scott Gottlieb to head up the FDA under his administration, MobiHealthNews noted that he had a history of advocating for a hands-off approach to mobile health regulation. Now, just three months later (and a little over a month after his confirmation to the post), Gottlieb has articulated his new -- and somewhat radical -- approach to mobile...
March 13, 2017
With previous rumored Trump picks to lead the FDA, we’ve had to rely on speculation to gauge their approach to mobile and digital health. Not so with former FDA deputy commissioner Dr. Scott Gottlieb, Trump’s final pick as of Friday.
Gottlieb, who will still have to be confirmed by the Senate, has made his feelings about mobile health regulation very clear. In 2014, he co-authored a piece for...