This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or conditionally approved) investigational...more
7/26/2019
/ Clinical Trials ,
Food and Drug Administration (FDA) ,
Investigational Device Exemptions ,
IRB ,
Life Sciences ,
Medical Devices ,
Medical Research ,
New Guidance ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
Reviewability Determinations
In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products, including radiation-emitting medical devices....more
On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more
On October 18, 2018, FDA issued a long-awaited draft revision to its existing guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"(premarket cybersecurity guidance). This coincided...more