Devices

FDA Proposes 2nd Section 518(b) Order for Philips

FDA is proposing that a Section 518(b) order be issued to require Philips Respironics to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after 11/2015.

In 6/2021, FDA says, Philips recalled certain ventilators, bi-level positive airway pressure, and continuous positive airway pressure machines due to potential health risks. The statement says the polyester-based polyutrethane foam used in the devices to lessen sound and vibration can break down. If this occurs, it says, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device.

The agency statement says the proposed order is in addition to its 3/2022 Section 518(b) order requiring the company to provide notification to customers of the recall and the health risks presented by the recalled devices. The agency says the first order was necessary due to “inadequate” company notification efforts.

Philips has an opportunity for an informal hearing before FDA determines whether to issue the new order for a company plan to repair, replace, or refund the units’ purchase price.

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