Podcast: KHN’s ‘What The Health?’ What’s Next For The FDA?
From Kaiser Health News Network – Their latest podcast, What the Health, This week, The resignation of Scott Gottlieb as commissioner of the Food and…
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Talent Tuesday – Job Opening at FDA
FDA Commissioner Scott Gottlieb announced he will be leaving his position next month. The White House has confirmed a resignation was not requested. Reason for departure only states that he wants to spend more time with his family.
MU Orthopaedic Surgeon Begins FDA-Approved Study for Novel Knee-Cartilage Implant
Seth L. Sherman, MD, a sports medicine orthopaedic surgeon at University of Missouri Health Care’s Missouri Orthopaedic Institute, recently became one of the first American…
Podcast: KHN’s ‘What The Health?’ Health Nerd Books For The Holidays
From Kaiser Health News Network – Their latest podcast, What the Health, episode 73, This week, The Food and Drug Administration took some serious steps…
HITECH and the FDA’s Overhaul of Medical Device Approvals
By Kayla Matthews – Since 1976, the U.S. Food and Drug Administration (FDA) has offered a fast-track approval process for medical device manufacturers that could prove their products were substantially similar to approved items that were already in the marketplace.
Podcast: KHN’s ‘What The Health?’ A Detour On A Smoking Off-Ramp
From Kaiser Health News Network – Their latest podcast, What the Health, episode 63, This week, The Food and Drug Administration declared that vaping among…
FDA Acts on Radiological CDS
By William A. Hyman – The FDA took two recent actions in the domain of CDS for radiological image interpretation. One was to permit the marketing under the De Novo program of software for the interpretation of fractures of the wrist.
FDA Asks for Input on Software That Isn’t a Medical Device
By William A. Hyman – It has long been clear that the FDA can regulate software that falls under the definition of a medical device. Such software might be part of and integral to a more physical chunk of technology.
FDA and Digital Health Regulation
By David Harlow – The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Collectively, these guidances cover a range of digital health issues.