Devices

FDA Sees No Justification for More Device Servicing Regs

FDA says currently available objective evidence is not sufficient to conclude whether there is a widespread public health concern related to servicing of medical devices that would justify imposing additional or different burdensome regulatory requirements at this time. That position is stated in a 5/2018 agency report on the quality, safety, and effectiveness of servicing of medical devices issued as required by the FDA Reauthorization Act of 2017.

The agency based its analysis on information presented at a public workshop, responses to a request for comments, and evaluation of objective evidence related to the quality, safety, and effectiveness of medical device servicing.

The objective evidence, the report says, indicates that many original equipment manufacturers and third-party entities provide high quality, safe, and effective servicing of medical devices.

FDA found that a majority of comments, complaints, and adverse event reports alleging that inadequate “servicing” caused or contributed to clinical adverse events and deaths actually pertained to “remanufacturing” rather than “servicing.”

While the objective evidence does not justify new regulations, the report concludes, steps that CDRH will take include: (1) promoting the adoption of quality management principles; (2) clarifying the difference between servicing and remanufacturing; (3) Strengthening cybersecurity practices associated with servicing of medical devices; and (4) fostering evidence development to assess the quality, safety, and effectiveness of medical device servicing.

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