Devices

103 Novel Devices Granted Authorizations in 2021

Despite being one of the busiest years at CDRH due to Covid-19, the Center was still able to grant marketing authorizations for 103 novel devices last year, according to a just-released CDRH annual report. The pandemic has also highlighted how vulnerable supply chains are and the Center’s report outlined several actions to help ensure that patients and health care providers have timely and continued access to medical devices. It notes that FDA’s FY 2022 budget request is seeking $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program in CDRH. “The program will build on the work done to implement the CARES Act during the Covid-19 public health emergency, focusing on strengthening the domestic supply chain through investments in preventive measures, identifying potential medical product supply shortfalls, continuing surveillance and rapid intervention,” it says.

Regarding cybersecurity, CDRH sponsored the publication of best practices for basic threat-modeling concepts and processes related to medical devices – Best Practices for Communicating Cybersecurity Vulnerabilities to Patients.

Additionally, CDRH has worked to accelerate the adoption of advanced manufacturing in the medical device industry. For example, it funded a Landscape Assessment project to assess and benchmark advanced manufacturing efforts in the medical device industry compared to non-health care industries, the report says. It also launched an Advanced Manufacturing Clearinghouse, a collaborative and independent third party entity that identifies and evaluates promising advanced manufacturing technologies.

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