Devices

AdvaMed Critiques FDA Homologous Cell Use Guidance

AdvaMed says there are several items in an FDA draft guidance on homologous use of human cells, tissue, and cellular and tissue-based products (HCT/Ps) that industry views positively, and several areas where industry disagrees or believes that improvements are needed. In a 4/20 comment letter, it says the positive items are: (1) abandoning the term “main function” and replacing it with “basic function(s),” which should be clarified; (2) acknowledging that basic functions and not just anatomical location determine homologous use; (3) allowing HCT/Ps to possess both structural and non-structural attributes and describing the “basic function or functions” of structural and non-structural tissue; (4) recognizing that dermis is separate from epidermis in terms of properties and function; (5) defining “repair, reconstruction, replacement, or supplementation”; (6) acknowledging that claims should be supported by evidence; and (7) acknowledging that the science related to homologous use may evolve.

The letter says that aspects of the draft guidance with which AdvaMed’s members disagree or believe should be improved include: (1) the narrow definition of homologous use of amnion provided in the draft; (2) “manufacturer’s objective intention,” which speaks to intended use beyond what a manufacturer has put in the labeling, is inconsistent with FDA’s currently proposed regulation related to “intended use,” and suggests a policy change that should go through formal notice and comment rulemaking.

AdvaMed calls on FDA to cite more specific examples to provide context to the agency’s decision-making process. It said this could be done as an appendix to the guidance in a tabular format that would be updated periodically.

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