Devices

MITA Concerns With FDA Remanufacturing Guidance

The Medical Imaging & Technology Alliance (MITA) says it is concerned that an FDA draft guidance on remanufacturing of medical devices will not achieve its intended outcome given that the agency is relying on third-party servicers and independent service organizations (ISOs) to comply with the guidance. A MITA 9/22 comment letter says the third-party servicers and ISOs:

are not regulated by FDA;
do not seek or follow FDA policy, regulations, or guidance;
conduct activities regarding medical devices that are unregistered and thus unknown to FDA;
do not have established quality management processes and documented procedures; and
do not report device malfunctions resulting from their servicing activities.

“Until FDA removes its enforcement discretion, requires all third-party servicers and ISOs to comply with registration, regulatory quality and safety requirements, and proactively exercises appropriate oversight (i.e., inspections) and enforcement policies, the current servicing activities constituting unregulated remanufacturing of medical devices will continue,” MITA declares.

The association says it supports expedient finalization and enforcement of the guidance and provides comments relating to regulatory requirements for remanufacturing, risk assessment, activities that likely constitute remanufacturing, considerations for labeling, and implementation and enforcement. The letter also includes line-by-line technical 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