Devices

QS, MDR Issues Seen in Exactech Inspection

A 9/18-9/26/2023 FDA inspection at the Exactech facility in Gainesville, FL, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of orthopedic implants and accessories. A just-released 1/19 Warning Letter says specific violations were:

failing to adequately establish procedures for corrective and preventive actions;
failing to establish and maintain design validation procedures to ensure proper risk analysis is completed;
failing to adequately develop, maintain, and implement written Medical Device Reporting procedures; and
failing to submit a report to FDA no later than 30 days after the company received information reasonably suggesting that a device it markets had malfunctioned and that this device or a similar one that it markets would be likely to cause or contribute to a death or serious injury.

The letter says FDA was unable to evaluate the firm’s responses to the inspection observations.

Exactech was told to take prompt action to address the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.

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