Devices

FDA Issues Surgical Staple Order, Guidance

FDA has issued a proposed order reclassifying certain surgical staplers and a draft guidance to help manufacturers ensure their surgical stapler and staples labeling provides adequate directions for use. CDRH director Jeffrey Shuren says the agency alerted the public and healthcare professionals 3/2019 about concerns with surgical staplers for internal use and implantable surgical staples. He says the agency alert warned about the identified risks and provided recommendations to help improve the safe use of the devices given their health benefits in a surgical setting.

The proposed order would reclassify surgical staplers for internal use from Class 1 (general controls) to Class 2 (special controls) and would subject them to premarket review. “FDA is proposing this reclassification on its own initiative based on new information,” the order says. “As part of this reclassification, FDA is also proposing to amend the existing classification for ‘manual surgical instrument for general use’ to remove staplers and to create a separate classification regulation for surgical staplers that distinguishes between surgical staplers for internal use and external use.”

The draft guidance says the agency has “become aware of a large number of adverse events associated with use of both surgical staplers and staples for internal use. Both device misuse and device malfunctions are root causes of these adverse events. FDA believes that these problems may be mitigated by providing specific information about the risks, limitations, and directions for use in the labeling for the surgical staplers and staples internal use.”

Finally, FDA says the 5/30 meeting of the Medical Devices Advisory Committee’s General and Plastic Surgery Devices Panel will discuss whether the current pathway for manufacturers to market surgical staplers for internal use is appropriate and will receive expert input on the proposed reclassification and draft guidance.

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