The U.S. FDA managed to wrap up a guidance for clinical decision support (CDS) products after several years, one of several projects the agency was liable for in the area of digital health. While a much-needed draft guidance for change control for artificial intelligence algorithms made the guidance agenda for the FDA’s new fiscal year, that draft is only a B draft guidance priority, suggesting that a final guidance might not emerge until calendar year 2024, possibly later.
The fifth medical device user fee agreement (MDUFA V) included several new programs, such as a program intended to aid device makers in an efficient to-market process. However, MDUFA V also boosted device user fees for many applications by 55% but turnaround times for these applications will remain essentially flat compared to MDUFA IV.
Continuous positive airway pressure (CPAP) devices made by Philips Respironics Inc. are still presumed by the U.S. FDA and other regulators to present a health hazard to patients, but the company’s latest data seem to suggest otherwise. In a Dec. 21 statement, the Royal Philips subsidiary said that testing suggests no appreciable harm to health related to particulate matter emissions from the polyester-based polyurethane (PE-PUR) foam in these devices, and that there is no evidence of long-term harm associated with volatile organic compounds (VOCs), both of which are conclusions with which the FDA may not agree.
Congress has wrapped up the budget for fiscal year 2023 with yet another significant boost to funds for the National Institutes of Health, but the omnibus legislation also authorizes the U.S. FDA to designate academic research centers as centers of excellence for continuous drug manufacturing. A conspicuous omission from the omnibus was the Verifying Accurate, Leading-edge IVCT Development (VALID) Act for FDA regulation of lab-developed tests (LDTs), an omission that drew both praise and criticism from stakeholders.
The U.S. False Claims Act (FCA) provides one of the more potent legal weapons in the federal government’s enforcement arsenal and three companies felt the sting of the FCA in the closing weeks of December 2022. Advanced Bionics LLC fell under the sway of the FCA related to allegations that it misused a performance standard in its premarket filing for cochlear implants, while Biotelemetry Inc. and its Cardionet LLC subsidiary will fork over more than $44 million for improper claims filed with the Medicare program.
The European Union’s efforts to update its regulatory framework for medical devices was heralded as a long-overdue response to the Poly Implant Prothèse (PIP) breast implant scandal, but the COVID-19 pandemic added significant drag to the implementation timelines. Those timelines have proven impracticable for other reasons as well and the problem will bleed into the new year and perhaps beyond to the detriment of patients and manufacturers.
With yet another deadline looming for passage of spending bills for the U.S. federal budget, Congress has drafted an omnibus spending bill that would extend coverage of Medicare telehealth services. The problem with the legislation in the eyes of many stakeholders is that the Verifying Accurate Leading-edge IVCT Development (VALID) Act is not part of the package that must be passed by Dec. 23, an omission that leaves lab-developed tests (LDTs) in a nether world of regulatory ambiguity.
The U.S. FDA has had a long-standing guidance dealing with drug manufacturing facilities that delay or deny FDA investigators’ attempts to inspect a manufacturing facility, but that policy was exclusive of device manufacturing facilities up until passage of the FDA Reauthorization Act (FDARA) of 2017. FDARA’s expansion of the policy to include device manufacturing facilities has prompted a rewrite of an existing 2014 guidance.
The FDA posted a recall announcement for two catheter kits made by Arrow International LLC, a subsidiary of Wayne, Pa.-based Teleflex Inc., due to problems with the connectors used in the kits. While no injuries or deaths have been reported, the problem could lead to embolism and/or delayed delivery of needed therapeutic fluids to patients, making this a class I recall due to the risk of injury and death.
U.S. federal authorities have made a lot of noise over inappropriate medical testing in the past two years, largely due to the COVID-19 pandemic, but Paul Garcia, a partner in the San Diego office of Hooper, Lundy & Bookman PC, says this trend will not ebb at all in the coming year. Garcia told BioWorld that the lookback period for Medicare testing claims runs several years and that not only will enforcement results continue to surface next year, but also that the associated civil monetary penalties could force a testing lab to shutter its operations permanently.
