Devices

Amco Illegally Selling AED Batteries: FDA

A 3/11-3/20 FDA inspection at the Amco International Manufacturing & Design manufacturing facility in Brooklyn, NY, determined that it manufactures replacement batteries for automated external defibrillators (AED) and that the medical devices do not have an approved PMA in effect. A just-released 6/25 Warning Letter reviews the regulatory history of the requirement that AED accessories were required to have an approved PMA as of 2/3/2022.

“FDA has determined that your firm has not submitted a PMA by the 2/3/2022 compliance date for these devices and that your firm has continued to manufacture and distribute these devices after the compliance date,” the letter says. The lack of an approved PMA renders the devices adulterated, FDA says.

The agency asked Amco to stop activities that result in the adulteration of necessary AED accessories. It told the firm to take prompt action to correct the violation and to respond with a list of specific actions it has taken to address the violation and prevent its recurrence, with documentation of the corrective action and a schedule for completing it.

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