Devices

CDRH Webinar Explains 2 De Novo Guidances

A CDRH 11/21 webinar described two guidances relating to the de novo program. A final guidance, De Novo Classification Process (Evaluation of Automatic Class III Designation, provides updated recommendations for interacting with FDA, including what information to submit when seeking a path to market via the de novo classification process. A draft guidance, Acceptance Review for De Novo Classification Requests, is not in effect, but is available for comment.

CDRH Office of Device Evaluation de novo program lead Sergio de del Castillo said the finalized guidance summarizes the legal foundation for de novo classification and the significant statutory changes that have occurred over time and that affected the de novo program.

De del Castillo reviewed the guidance eligibility section, saying it is one of the most key areas sponsors should be concerned about in determining whether a product is eligible for de novo classification.

Devices going through the de novo process must not have a predicate and cannot fit into any existing Class 1, 2, or 3 classification regulation. “Earlier interaction with the agency can be beneficial to both you and the agency when determining whether or not something is in fact appropriate for de novo classification,” he said. “And we can do that through our pre-submission process. If, in fact, we determine that the product is appropriate for de novo classification, it would also be a great opportunity to identify the valid scientific evidence that would be needed to support your future de novo request.”

Referring to the draft guidance, de del Castillo said that when finalized, it would ensure that a de novo request meets a minimum threshold of administrative completeness so FDA could conduct a substantive review. He said the de novo submission checklist in the guidance is very similar to that for 510(k)s and PMAs.

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