Devices

FDA Guide on Requesting Rationales of Significant Decisions

FDA has posted a guidance on “Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A.” Section 517A of the Food, Drug, and Cosmetic Act was amended by the recent 21stCentury Cures Act of 2016 to allow requests for documentation of rationales for “significant decisions” and requests for supervisory review of regulatory decisions and actions taken by the Center. According to the guidance, 517A decisions requiring the rationales include:·

510(k) not substantially equivalent; substantially equivalent·
PMA/HDE: not approvable; approvable; approval; denial·
Breakthrough devices: granting; denial·
IDE: disapproval; approval·
Failure to reach agreement on a protocol
Clinical hold determinations

For decisions that are subject to the provision, FDA says the substantive summary may be the final version of the review memorandum by the lead reviewer or another summary document that includes the following elements:·

An explanation of the rationale for the regulatory decision;·
An explanation regarding how least burdensome requirements were considered and applied
Documentation of significant controversies or differences of opinion, i.e., ones the resolution of which had a direct bearing on the regulatory decision; and,·
References to published literature and consensus standards upon which the decision-maker relied

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