Devices

Virtual Meeting on Device Patient-Reported Outcomes

FDA has announced a 9/30 virtual public meeting entitled “Patient-Reported Outcomes (PROs) and Medical Device Investigations: From Conception to Implementation.” The meeting is intended to discuss the benefits and challenges of incorporating patient perspectives in regulatory decision making using PRO instruments.

The meeting is part of CDRH’s commitment to include the patient’s voice during the design and evaluation of medical devices. “The use of well-developed patient-reported outcome (PRO) instruments helps to accomplish this in a structured, well-defined, and reliable way,” a Center notice says. “These instruments (also called tools) include questionnaires, diaries, and numeric rating scales used to collect information directly from the patient about their health status and are not subject to interpretation by a healthcare provider or outside observer. Increasingly, PRO instruments are being used in clinical care to help evaluate medical conditions, being integrated into clinical investigations, and of importance to payers and regulators.”

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

Read more

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