Two makers of breast implants failed to comply with years-old FDA post-approval study orders, and TEI Biosciences Inc. – an Integra LifeSciences company – ran afoul of the US agency's Quality System Regulation in device-related warning letters released by FDA this week.

The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.

Total Thermal Imaging, a company that promotes thermal imaging technology over mammography to detect breast cancer, says it is surprised the agency is coming after them for "illegally marketing" their test for unapproved indications. The company says it thought it had complied with all of FDA’s requirements but  is willing to consider filing a 510(k) if needed.

Intra-aortic balloon pump manufacturer Datascope was cited for quality systems violations, and maker of the Thermography Business Package for thermal imaging was cited for pre-market violations in the only device-related warning letters released by US FDA this week.

A Beverly Hills doctor was slapped with a US FDA warning letter for quality systems, Medical Device Reporting and pre-market issues related to a device used during breast augmentation procedures, and an Oyster Bay, NY, specification developer of the Better Bladder device was instructed by the agency to hire a consultant to help fix its quality systems issues. Two other missives were released this week – the first device-related warning letters posted online by FDA since early December 2018.

Device manufacturers would be able to get nonbinding feedback on their plans for how to resolve some Form-483 inspectional observations from US FDA officials under a new draft guidance released Feb. 15.

A clear, succinct problem statement is the backbone of a winning device failure investigation, Karl Vahey says. He notes that a well-developed statement is also useful to have on hand when regulators conduct a facility audit and review corrective and preventive action (CAPA) activities.

The upcoming voluntary global standard F3306 aims to improve the safety of surgically implanted medical devices. F3306 describes a novel test method that assesses metal and other ions released from single-use, metallic, implantable devices, and their components.

While the number of recalled products fell 1% in the fourth quarter of 2018, the number of recalled device units spiked dramatically. Machine failure was the top recall cause based on units, while software was blamed for causing the most recalled products for the 11^th consecutive quarter. Check out our Q4 recalls infographic.