Devices

Sponsors Must Self-Identify Combination Products: FDA

CDRH reviewed in a 3/20 Webinar contents of two updated guidances that implement provisions of the 21^st Century Cures Act — the acceptance and filing a review for PMA applications guidance and the refuse-to-accept policy for 510(k) guidance. CDRH Office of Device Evaluation policy analyst James Bertram said the Cures Act requires sponsors of combination products to appropriately self-identify their product as such. And, if the product is a device-led combination and includes a drug constituent that was previously approved by CDER, the sponsor must provide the appropriate patent certification and consider whether any NDA is protected by exclusivity.

Bertram said the agency has updated its refuse-to-accept checklist to take into account these new provisions, helping to ensure that the necessary information is present for the agency to make its decisions.

“In summary,” Bertram said, “to ensure compliance with the provisions set forth in Cures regarding combination product self-identification, we recommend that you include a statement in your cover letter and product description that basically states that you identify your product as a combination product.”

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