Devices

510(k) Third Party Review Guidance Out

FDA has issued a guidance, 510(k) Third Party Review Program, describing the process FDA uses to recognize qualified third parties to conduct the initial review of 510(k) submissions for certain low-to-moderate risk device eligible for review under the CDRH Third Party 510(k) (3P510k) Review Program. The document also reflects amendments made by the FDA Reauthorization Act of 2017 that directed the agency to issue guidance on the factors that will be used in determining whether a Class 1 or Class 2 device type or a subset of such device types are eligible for review by an accredited person.

The guidance’s objectives are: (1) to describe the factors FDA will use in determining device type eligibility for review by 3P510k review organizations; (2) to outline the agency’s process for the recognition, re-recognition, suspension, and withdrawal of recognition for the 3P510k review organizations; and (3) to ensure consistent quality of work among 3P510k review organizations through the MDUFA 4 commitments authorized under the FDA Reauthorization Act to eliminate the need for routine, substantive re-review by FDA.

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