Devices

QS, MDR Violations at Future Diagnostics

A 1/16-1/19/2023 FDA inspection at the Future Diagnostics Solutions facility in Gelderland, Netherlands, found Quality System and Medical Device Reporting violations in the firm’s manufacturing of the STAT-IntraOperative Intact PTH (parathyroid hormone) Immunoassay Kits. A just-released 5/11/2023 Warning Letter says the devices are adulterated due to these Quality System Regulation violations:

failure to verify or validate corrective and preventive actions to ensure that they are effective and do not adversely affect the finished device;
failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, including the identification, documentation, evaluation, segregation, and disposition of nonconforming product, and to ensure that the evaluation includes a determination of the need for an investigation;
failure to establish and maintain procedures for identifying valid statistical techniques and to ensure that sampling plans are adequate for their intended use; and
failure to adequately establish procedures for quality audits and to conduct such audits to ensure that the quality system complies with the established quality system requirements and to determine quality system effectiveness.

The letter also says the company’s kit is misbranded due to its:

failure to adequately develop, maintain, and implement written Medical Device Reporting procedures; and
failure to submit a report to FDA no later than 30 days after it received or otherwise became aware of information that reasonably suggested that a device it markets had malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Future Diagnostics was told to respond with a list of specific steps it has taken to address the violations and prevent them from recurring, with documentation of the actions and a schedule for completing the corrections.

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

Read more

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