Medical Device Legal News with Sam Bernstein: Episode 11
The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates. The FDA just released new draft...more
On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more
Health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease state management such as for cancer,...more