Devices

AdvaMed Backs Coverage of all IDE Trials

Commenting on an FDA draft guidance on categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions, AdvaMed says it supports CMS coverage of all IDE trials. The comment letter says that in recent years CMS declined to cover only 3% of IDEs (non-coverage of both routine patient care costs and the investigational device).

The letter notes that trials are considered to be either Category A or Category B, and it supports the guidance policy clarification that IDEs may transition between the two categories. CMS covers device costs as well as routine patient care costs for Category B studies, AdvaMed says, but only routine patient care costs associated with Category A studies. To facilitate changing a Category A IDE to Category B, the trade group urges FDA to clarify in the final guidance the broad range of data sponsors can rely on to request a change of IDE category, including peer-reviewed studies, pre-market or post-market non-U.S. data on the same or similar device types, additional non-clinical data on the same or a similar device, and commercialization of a similar device type of preliminary clinical data on the device.

The 510(k) Coalition says it supports many of the ideas in the draft and the clarity it strives to offer. To increase the document’s usefulness, the coalition recommends adding links to documents referenced in the guidance. The coalition says the guidance does not clarify the process for switching an IDE from Category A to Category B and recommends that it address issues such as timelines on decisions for changing categories and the process a sponsor should follow in making such a request. It calls on FDA to ensure that the clinical trial sponsor is involved in the information collection and decision process.

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