Dublin-based Medtronic plc, and the U.S. FDA have wrapped up their discussion of the December 2021 warning letter for the company’s manufacture of continuous glucose monitors, clearing a hurdle that was critical in restoring the company’s footprint in the U.S. market. Left unanswered from the resolution of the warning letter is whether the FDA believes that device makers need to track the number of devices in distribution vs. those in actual use in order to properly calculate the risk of device failure based on postmarket surveillance.
The U.S. Supreme Court has declined to hear a case that tests the notion that artificial intelligence (AI) can be an inventor, a development that may be nothing more than the beginning of the AI-as-inventor story under U.S. law. The Patent and Trademark Office’s (PTO) April 25 webinar on the subject included some remarks that AI could be used to produce a tsunami of potentially duplicative patent applications, but the event demonstrated that there is almost no at-large support for AI-as-inventor, suggesting that the status quo will stand for the time being.
The U.S. Supreme Court has declined to hear a case that tests the notion that artificial intelligence (AI) can be an inventor, a development that may be nothing more than the beginning of the AI-as-inventor story under U.S. law. The Patent and Trademark Office’s (PTO) April 25 webinar on the subject included some remarks that AI could be used to produce a tsunami of potentially duplicative patent applications, but the event demonstrated that there is almost no at-large support for AI-as-inventor, suggesting that the status quo will stand for the time being.
The U.S. Supreme Court has handed down a broadly unanimous decision that allows the targets of Federal Trade Commission (FTC) enforcement action to appeal that action to federal district court prior to the conclusion of the agency’s review or enforcement process. The outcome could prove a boon to life science companies that may now challenge FTC actions against mergers and acquisitions prior to the conclusion of that action, a point at which the company’s options have narrowed drastically.
Avanos Medical Inc. recalled 1,000 units of two of its Ballard Access suction systems for use in clearing artificial airways in neonatal and pediatric patients because of multiple complaints of cracked device manifolds. The recall affects 1,000 units distributed in the U.S. between October 2022 and January 2023, but this is the second recall of Avanos products in less than a year.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is a groundbreaking guidance that was enabled by legislation that allows the filing of PCCPs with all device types, not just software as a medical device (SaMD). However, a member of the FDA team acknowledged recently that this new approach to device change management could require that the agency revisit existing guidances such as a guidance for when to file a new regulatory submission for 510(k) devices, thus heralding a series of guidance revisions that may take several years to unwind.
The U.S. Supreme Court has handed down a broadly unanimous decision that allows the targets of Federal Trade Commission (FTC) enforcement action to appeal that action to federal district court prior to the conclusion of the agency’s review or enforcement process. The outcome could prove a boon to life science companies that may now challenge FTC actions against mergers and acquisitions prior to the conclusion of that action, a point at which the company’s options have narrowed drastically.
The opioid crisis in the U.S. has not yet been resolved, but FDA commissioner Robert Califf said April 19 the agency could do more to resolve the crisis if Congress granted the agency the authority to require that new opioid analgesics offer superior safety relative to currently approved products. Califf laid the blame for the crisis on manufacturers in stating that drug makers had “let us down” in failing to develop novel oral analgesics that avoid the addictive properties that helped to fuel the opioid crisis.
The annual U.S. budget scrum is well underway in Washington, with drug pricing a persistent theme on Capitol Hill. Lawrence Tabak, acting director of the National Institutes of Health (NIH), said NIH’s view is that federal government exercise of march-in rights “is not the instrument to regulate drug pricing” as it would alienate drug makers and their investors, but Tabak vowed that the appropriate use of march-in rights is the subject of intense focus at the Department of Health and Human Services.
There are worse things for U.S. FDA-regulated companies than a warning letter from the agency, but both Abbott Point of Care Canada Ltd., and North American Diagnostics LLC were hit with a warning letter that included citations for failure to comply with the Quality System Regulation (QSR). North American may have believed it was no longer required to comply with the QSR as it ceased the manufacture of its COVID-19 rapid antigen test kits in July 2021, but the FDA advised the company that compliance is required so long as there is some chance that an adverse event arises in connection with the company’s product.
