Devices

Software Clinical Evaluation Guidance Out

FDA has published an International Medical Device Regulators Forum guidance, Software as a Medical Device (SaMD): Clinical Evaluation, in an effort to establish a “common and converged understanding of clinical evaluation and principles for demonstrating the safety, effectiveness, and performance of software intended for medical purposes” as defined in a companion definitions document. This guidance says the principles for clinical evaluation are the same for all medical devices and the expected rigor in current clinical guidance is intended to be technology agnostic.

“SaMD, a type of medical device, also has significant patient and public health impact and therefore requires reasonable assurance of safety, effectiveness, and performance,” the document says. “This assurance for SaMD is expected to be provided through a systematically planned clinical evaluation approach that generates adequate scientific evidence to create transparency, and to assure confidence in the SaMD’s clinical validity for the intended purpose and indications for use, namely the claims, of the SaMD. This evaluation along with the evidence helps demonstrate that the SaMD is safe, that it performs as intended, and that the risks associated with the use of the SaMD are acceptable when weighed against the benefits to patients.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome