Devices

Pre-Cert Working Model 1.0 Discussed

CDRH associate director for digital health Bakul Patel says the 1/7 release of version 1.0 of the Center’s pre-certification working model also included release of a test plan and regulatory framework. In a 2/7 Webinar on the releases, Patel said that in version 1.0 CDRH emphasized that the program is all about the total product lifecycle. “We are emphasizing that we are in the excellence appraisal process, and we describe what that detail looks like,” he said. “We are also looking at how we create a system where there are minimal questions on what category a product fits into, aligning with the international medical devices regulatory form or framework.”

The new version also proposes a list of review elements, Patel explained, saying the Center believes that if excellence appraisal and the redetermination happen, those are the components that are important for CDRH to review.

“These are proposals that we are going to test and I will share with you how we are going to do that,” he said.

Patel said the Center is moving from an episodic oversight to a sort of continuous oversight in which staff not only look at one point but look throughout the product lifecycle.

For the testing program, CDRH is proposing using the de novo pathway to look at the information used in the excellence appraisal, the redetermination and streamline review in totality to assure that a product’s risks are managed and controlled.

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