Devices

Third-Party Review Guidance Explained

CDRH Office of In Vitro Diagnostics policy analyst Allen Hill says the 510(k) third-party review program explained in a 3/12 guidance enhances quality in several ways. Speaking during a 4/16 Webinar on the guidance, Hill said the quality enhancements are that the agency has the right devices eligible for the program, the agency receives quality reviews that can be verified through a supervisory review, and the agency can ensure that only quality third-party review organizations remain in the program.

Hill said CDRH wants to be sure that the “right devices” are eligible for the program. Factors that were considered in deciding which devices are eligible were lower risk, well-understood, and lack of post-market safety signals.

The 510(k) third-party review program is a voluntary alternative, Hill said. It operates in this way: (1) the submitter identifies an appropriate third-party to review its 510(k); (2) the submitter sends the eligible 510(k) to the third party; (3) the third party reviews the 510(k), resolves any differences they find, documents their review, and sends a recommendation to FDA, and (4) FDA does a supervisory-level review to make a final decision.

“It’s important to note the interactive nature of the process,” Hill said. “Everyone can be part of the conversation and talk with each other. The third party is the primary contact point.”

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