Devices

Guidance on ISO-10993-1 Explained

Three Hogan Lovells attorneys say FDA published 9/8 an updated final guidance on using the international standard ISO 10993-1, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process. Writing in an online post, the attorneys say the guidance further harmonizes the agency’s guidance for assessing the biocompatibility of medical devices with international standards. It also updates the version of the guidance that was published in 2020 to reduce testing requirements to support the biocompatibility of products that have been modified in ways that do not alter their established biocompatibility or are new or modified devices that contact only intact skin, and which are fabricated using common, well-established materials.

The post looks at emerging trends in biocompatibility reviews at FDA and alternative proposals that deviate from FDA-recognized ISO 10993 that the testing industry is considering, including benchtop models that may alleviate the need for certain animal studies.

The attorneys say the biocompatibility factors that FDA is generally interested in are:

identification of the tissue with which a medical device or part of a device comes into contact;
whether the contact is direct or indirect;
how long the device is in contact with tissues; and
what the device is made from.

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