Devices

FDA Extends UDI Compliance Date for Low-Risk Devices

CDRH says it intends to extend the compliance dates for the unique device identification (UDI) system requirements for low-risk medical devices (certain Class I and unclassified devices), such as manual surgical instruments and mechanical wheelchairs. The Center and industry have already implemented requirements for higher-risk medical devices (Class III; implantable, life-supporting or life-sustaining; and Class II devices), including implants and other devices that support and sustain patients’ lives, such as artificial joints, heart valves and automated external defibrillators.

The Center says many UDI labelers have asked for extensions to comply aith the agency requirements. “In addition, we identified complex policy and technical issues that need resolution, such as how UDI applies to products such as medical procedure trays that contain implantable devices and instruments,” a letter to device makers says. “For these reasons, we plan to engage with industry and other stakeholders to address existing challenges and optimize the quality and utility of the data for higher-risk medical devices already in the system before adding lower-risk medical devices. Taking the time to do this now will help ensure the transition from development of the UDI system to widespread use and sustainability... In order to extend the compliance dates for lower-risk medical devices, the FDA plans to issue a guidance document to provide an enforcement discretion policy for labeling, data submission, standard date formatting, and direct mark requirements for Class I and unclassified devices.”

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