Devices

AdvaMed Comments on FDA Device Remanufacturing Guidance

AdvaMed says it supports FDA efforts to clarify which activities performed on medical devices are remanufacturing or servicing. In a 9/22 comment on an agency draft guidance, the association says that much device servicing performed by third-party servicing entities is actually remanufacturing and subject to FDA remanufacturing requirements.

“Guidance clarifying the difference between remanufacturing and servicing can help guide third-party servicers in understanding when their activities are subject to FDA regulation,” the comment letter says. “Additionally, clearer distinction between these activities will appropriately limit third-party servicers to routine servicing activities or, alternatively, illustrate that it is subject to the Quality System regulation and FDA submission requirements. Such an approach preserves the intended use and performance of the device and furthers patient safety.”

Because many third-party servicers will be unfamiliar with the regulatory requirements and terminology that are intrinsic to the draft guidance, AdvaMed says, FDA should work to simplify that guidance so that individuals who are not educated in regulatory requirements and terminology will understand their responsibilities under the guidance.

The comment letter offers suggestions relating to the education of third-party servicing entities on the existence of the guidance; aligning the title with the guidance purpose; the scope of the guidance document; the definitions section; changes involving software and cybersecurity issues; considerations for labeling; and enforcement of the guidance. The letter also contains specific line-by-line comments.

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