Devices

FDA Pulls 2 Medical Device Proposed Rules

Saying they are not currently considered viable candidates for final action, FDA is withdrawing two proposed medical device rules. An 11/1 Federal Register notice says that as part of its regulatory reform process, the agency reviews the backlog of proposed regulations that have not been finalized.

The two proposed rules that are being pulled are:

a proposed amendment to the performance standard for laser products first published 6/24/13 that cites an international performance standard that is being revised to reflect advancements in technology; and
electronic submission of labeling for certain home-use medical devices first published 10/17/16 that received several adverse comments on a proposed FDA-managed labeling database and concerns about the proposed format and potential industry costs.

“The withdrawal of these proposals … does not preclude the agency from reinstituting rulemaking concerning the issues addressed in the proposals…,” the notice says. “Should we decide to undertake such rulemakings in the future, we will re-propose the actions and provide new opportunities for comment.”

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