Devices

FDA Proposes Special 510(k) Update, Clarification

FDA has issued a draft guidance, The Special 510(k) Program, that would update the Special 510(k) program to clarify existing policy and expand on the types of changes eligible for the program to improve the efficiency of 510(k) review. The agency says the update includes certain changes to the indications for use and clarifies the types of technological changes that are appropriate to be reviewed as Special 510(k)s. Comments on the draft guidance will be received by the agency until 11/27.

The document says its intent “is to describe an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and rigorous design control procedures produce highly reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial evidence. These well-defined modifications may include certain changes to indications for use that are not currently within the scope of the Special 510(k) program. The draft guidance also clarifies the types of technological changes eligible to be reviewed as Special 510(k)s. Specifically, we are proposing to evaluate whether design and labeling changes can be reviewed under a Special 510(k) by focusing on whether the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format.”

Specifically, the agency proposes that a design or labeling change to an existing device (including certain changes to indications for use) may be reviewed under a Special 510(k) when:

the proposed change is made and submitted by the manufacturer authorized to market the existing device;
performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change; and
all performance data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format.

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