Devices

Least Burdensome Guidance Outlined

A 3/14 CDRH Webinar discussed the 2/5 final guidance on concepts and principles of the “least burdensome” regulatory information provisions. CDRH Office of Device Evaluation regulatory advisor Joshua Silverstein said the guidance describes the agency’s use of the least burdensome approach through medical device regulation to remove or reduce unnecessary burdens that could delay marketing of beneficial products while maintaining the legal requirements for clearance and approval.

He reported that 79 comments were received on the draft guidance from 13 external stakeholders. Most of the comments supported the proposal, he said, and there were revisions and additional requests on the least burdensome definition and guiding principles.

The seven least burdensome guiding principles identified by Silverstein from the guidance are:

FDA intends to request the minimum information necessary to adequately address the regulatory question or issue at hand;
industry should submit material including pre-market submissions to FDA that are least burdensome for FDA to review;
FDA intends to use the most efficient means to resolve regulatory questions and issues;
the right information should be provided at the right time;
regulatory approaches should be designed to fit the technology, considering its unique innovation cycles, evidence generation needs, and timely patient access;
FDA intends to leverage data from other countries and decisions by or on behalf of other national medical device regulatory authorities to the extent appropriate and feasible; and
FDA intends to apply least burdensome principles in international medical device convergence and harmonization efforts.

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