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.
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.
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.
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.
By David Harlow – The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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.
By William Hyman – The 21st Century Cures Act addressed what kinds of medical software are medical devices (and therefore subject to regulation by the FDA), and what kinds are not medical devices (and therefore not regulated by the FDA, but subject to CPSC and FTC).
By Matt Fisher – Healthcare has become the proverbial shiny object to many technology companies, both within and without of Silicon Valley. The technology companies seem to view healthcare as a great, untapped wilderness that is flush with potential profits.
By William Hyman – One form of Clinical Decision Support (CDS) software is that which suggests one or more diagnoses or other important assessments based on some set of patient specific data.
By Matt Fisher – Mobile apps are a topic of frequent discussion in the healthcare field these days. Questions include what regulatory requirements apply, are the apps trustworthy, is information kept safe and secure, and others. The question of what regulations apply in particular leaves many confused and uncertain as to what needs to be done.
Medical Device Data Systems Pose Low Risk By Bakul Patel Thanks to advances in digital health, doctors and their patients are more frequently using computer systems to collect medical data that can provide useful information on a patient’s health. Some of these systems, referred to as “medical device data systems,” are off-the-shelf or custom hardware […]
Food and Drug Administration Safety and Innovation Act By Brian Ahier HHS released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT […]
FDA Posts Recall of Computerized Record System William A. Hyman Professor Emeritus, Biomedical Engineering Texas A&M University, email@example.com Read other articles by this author While EHRs are not regulated as medical devices, some similar products are regulated by the FDA and thus are subject to a number of FDA processes including publicly announced recalls. A case […]
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