Devices

Guide on IDE Categorization for CMS Coverage Decisions

FDA has issued a guidance on “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions,” which modifies the categorization of IDE devices used in clinical studies. Under the guidance, devices with an approved IDE fall into one of two categories: Experimental (Category A) devices or Nonexperimental/Investigational (Category B) devices, based on the risk the device poses to patients. The categorization is used by CMS to determine whether an IDE device, and certain services related to those devices, may be covered by CMS.

The agency says that on 12/2 CDRH and CMS’s Coverage and Analysis Group executed a memorandum of understanding (MOU) to streamline categorization to support CMS’s ability to make Medicare coverage determinations for those devices. The MOU notes the need for FDA and CMS to revise their shared understanding regarding categorization, and the guidance implements the MOU by describing the process and information that will be used to help the agency determine the category for an IDE and describe when the category assigned may be changed.

FDA is planning a 1/16/2018 Webinar to discuss the document and it will respond to questions from stakeholders.

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