Devices

510(k) Third Party Review EUA Guidance

FDA has published a draft guidance, 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review. The document says FDA may contract with third-party review organizations to perform reviews of emergency use authorization (EUA) requests when appropriate emergency declaration authorities are active.

The guidance says its objectives are to:

describe and distinguish FDA’s expectations for the third-party 510(k) review program (3P510k) and for third-party EUA (3PEUA) review;
describe the factors FDA will use in determining device type eligibility for review by 3P510k review organizations;
outline FDA’s process for the recognition, re-recognition, suspension, and withdrawal of recognition for 3P510k review organizations;
clarify the agency’s expectations for review under both 3P510k review and 3PEUA review for all stakeholders to ensure confidence and consistent quality of work by third-party review organizations to eliminate the need for routine, substantive re-review by FDA;
outline FDA’s expectations to prevent conflict of interest between the third-party review organization and other entities; and
describe FDA’s expectations regarding the compensation process between the third-party review organization(s) and other entities.

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