The U.S. Federal Trade Commission (FTC) finalized its overhaul of the health breach notification rule (HBNR), significantly expanding the types of software products subject to the agency’s oversight. However, the final rule was approved by the commission by a narrow 3-2 vote and was the subject of a scathing critique by the two dissenting commissioners, who argued that the FTC has once again exceeded its statutory authority in rewriting the HBNR.
Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products.
The U.S. FDA issued a handful of warning letters to device makers in the month of April 2024, one of which is for the Waukegan, Il., plant operated by Cardinal Health Inc., of Dublin, Ohio. While the Waukegan plant escaped citations for most routine Quality System Regulation deviations, the FDA said Cardinal’s handling of contract manufactured luer locks and syringes fell well short of the agency’s expectations given that these issues led to a massive recall, a product removal and an FDA advisory.
Medtronic plc said it secured U.S. FDA approval for its first closed-loop spinal cord stimulator (SCS), designed to take in signals from the body and adjust its therapy automatically.
The U.S. FDA’s senior managers often lament the lack of routine increases in taxpayer funding, a concern that Michael Rogers, the associate FDA commissioner for regulatory affairs, reiterated during a May 1 webinar. Rogers said the agency’s field inspectorate will be working through a large number of retirements over the next few years, a predicament he said will continue to be “a huge challenge” to overcome.
It’s been a year since U.S. FDA Commissioner Robert Califf first started talking about reforming the agency’s advisory committee process. Now the FDA is moving beyond talking about it to listening. The agency has scheduled an all-day listening session June 13 to get feedback on optimizing the use of adcoms and the processes involved.
U.S. Medicare coverage of products for leg and foot ulcers has undergone a second review in less than a year thanks to pushback from stakeholders after the August 2023 issuance of proposed non-coverage policies for more than 100 cell and tissue-based products.
Royal Philips NV has come to terms over class-action litigation in which plaintiffs alleged that particulate matter in continuous positive airway pressure (CPAP) machines has proven harmful to their health, bringing the matter to a $1.1 billion conclusion. Despite the 10-figure sum, news of the April 29 settlement sent the company’s share prices up by roughly a third in early morning trading, suggesting that investors had already baked their expectations of the settlement into their thinking about the company’s future.
In what represents its first patenting, PBSF Inc. filed for protection of brain monitoring and neuroprotection strategies for infants at high risk on a large scale.
The U.S. FDA’s final rule for regulation of lab-developed tests was hardly a shock to the world of regulation, but the final rule might provide a shock for sorts for smaller entities in the diagnostics space. Analysts with Leerink Partners said most companies they routinely track are unlikely to be immediately affected by the final rule, but noted that FDA regulation might make it tougher for smaller, new entries to the space to get to market.
RSS
