The U.S. FDA published a draft guidance for hydrogen peroxide-based contact lens care products (HPCPs), which up until 1997 were seen as class III products requiring a PMA. However, this draft is a response to an increasing number of adverse events associated with these products, a problem that was the subject of a 2017 FDA advisory hearing.
The doctrine of patent assignor estoppel is not found in the U.S. statute, but that omission has led to only limited litigation over the doctrine despite the notoriety of the case of Hologic v. Minerva. Nonetheless, the Federal Circuit reinforced the understanding that an assigned patent is still in force when the disputed claim is not seen has having been materially broadened by the time a patent has been granted in its final form, thus closing one of the principal contractual questions surrounding patents that are handed off from one device maker to another.
After five years, the U.S. FDA finally released a final rule for over-the-counter hearing aids along with an associated guidance, a development that was stipulated by the FDA Reauthorization Act (FDARA) of 2017. Xavier Becerra, Secretary of the U.S. Department of Health and Human Services, was among several HHS officials who appeared on the Aug. 16 briefing to tout the rule, each of which promised that the rule would spark competition that would in turn take a significant bite out of the cost of acquiring a hearing aid.
The field of artificial intelligence (AI) is beginning to mature, but this is also becoming a competitive space, with several governmental entities declaring their intent to develop policies to maintain national competitiveness. The U.S. has now entered the fray with a request for information by the International Trade Administration seeking information on policies that might foster the export of AI products developed by U.S. companies, but also on the policies that might enable small and medium enterprises to remain competitive.
After five years, the U.S. FDA has finally released a final rule for over-the-counter hearing aids along with an associated guidance, a development that was stipulated by the FDA Reauthorization Act (FDARA) of 2017. Xavier Becerra, Secretary of the U.S. Department of Health and Human Services, was among several HHS officials who appeared on the Aug. 16 briefing to tout the rule, each of which promised that the rule would spark competition that would in turn take a significant bite out of the cost of acquiring a hearing aid.
The link between the use of antipsychotic medications and the risk of sudden cardiac arrest may not have yet earned universal recognition among cardiologists, but the U.K. National Institute of Health and Care Excellence (NICE) has seen enough to believe the hypothesis has some merit. The agency recently proposed that the Kardiamobile 6L device by Alivecor Inc., of Mountain View, Calif., be covered for patients taking antipsychotic medications, a policy which if adopted would reflect what NICE sees as an unmet need for a population at grave risk.
It is one thing to watch a U.S. FDA inspection fail to meet with the agency’s expectations regarding compliance with the Quality System Regulation, but it’s another to have four opportunities to respond to the inspectional findings and still end up with a warning letter.
The question of whether an artificial intelligence (AI) algorithm should enjoy the status of an inventor has been making the rounds in various nations, but the U.S. Court of Appeals for the Federal Circuit has rejected the notion based on a plain reading of the statute. The court said that the statute is unambiguous in that only natural persons can claim inventorship, but the question will be appealed to the Supreme Court, which will have an opportunity to put this debate to rest.
Surgical mesh product liability litigation has fed a massive volume of billable hours for attorneys on both sides of these lawsuits, but a recent case went the way of Coloplast AS unit Coloplast Corp., of Minneapolis, which prevailed over a litigant in a case heard in a Minnesota district court. Despite the win, the case sustains an ongoing debate over whether the gatekeeping function for expert testimony was appropriately exercised, an issue that may soon be clarified by an advisory body on judicial procedures.
Implementation of the new regulations for medical devices and in vitro diagnostics in the EU have presented a number of problems, including a serious crunch in the availability of notified bodies (NBs) to review premarket filings.
