The U.S. Patent and Trademark Office (PTO) has released a guidance to aid patent examiners in dealing with questions of obviousness in patent applications, but patent attorney Michael Borella told BioWorld that this new guidance could resurrect the law of unintended consequences. Borella, a partner in the Chicago office of McDonnell Boehnen Hulburt & Berghoff LLP, said the guidance might lead to more inappropriate rejections of patent claims for obviousness, and thus make the process of obtaining a clean patent more difficult, not less.
The U.S. Department of Justice (DOJ) has released the metrics for prosecutions under the False Claims Act (FCA) for fiscal year 2023, ringing up recoveries of nearly $2.7 billion, the 15th consecutive year in which recoveries exceeded $2 billion.
The U.S. FDA’s approach to predetermined change control plans (PCCP) for medical devices has been widely viewed through the lens of artificial intelligence software, but the potential scope of PCCP is much broader than merely evolutionary software and iterative device designs.
Australia’s Therapeutic Goods Administration (TGA) proposed in July 2023 to develop a framework for audits for premarket device applications, but the Medical Technology Association of Australia (MTAA) registered several concerns about the proposal.
In recent years, the U.S. Congress has come to rely unduly on continuing budget resolutions to fund government operations, and fiscal year 2024 is no exception. The current continuing resolution (CR) for the FDA budget is set to expire March 1, but there is concern that Congress will resort yet again to a CR to cover the balance of fiscal 2024, a predicament which suggests that the FDA’s appropriations may be flat relative to fiscal year 2023.
The U.S. FDA issued an update to a previous advisory to doctors regarding the use of electromyogram endotracheal tubes made by Dublin-based Medtronic plc., but there is still some noise in the agency’s communications regarding this matter.
The U.S. FDA’s December 2023 draft guidance for the use of real-world evidence (RWE) for medical devices drew comment from across the spectrum of stakeholders, but industry is demonstrably wary of the draft on several points. The Medical Device Manufacturers Association (MDMA) offered several pointed criticisms, including that the draft seems to suggest that a fit-for-purpose study might be nearly indistinguishable from a conventional clinical trial, which MDMA said violates the least burdensome principle.
After nearly a decade and a half of service at the U.S. FDA, Bill Maisel will retire from the agency, taking with him a wealth of experience as both a physician and a regulator. The agency said Owen Faris, also a long-time member of the FDA staff, will take Maisel’s place as the director of the Office of Product Evaluation and Quality (OPEQ), but this is a temporary stint for Faris as the agency will conduct a search for Maisel’s replacement.
Third-party testing of medical devices is an established practice, but some testing labs are more reliable than others. The U.S. FDA has warned device manufacturers that some of these labs are turning out falsified data in connection with such testing, calling out labs located in China and India as unusually suspect sources of testing data.
The U.S. FDA’s device center has been prodding industry for some time to develop a culture of quality regarding the manufacture of medical devices, an emphasis that has resulted in the development of several programs. While the recent harmonization of the FDA’s device quality system regulation with an international standard might seem oblique to this culture of quality consideration, the FDA’s Keisha Thomas advised industry that the overhaul of the Quality System Regulation (QSR) is seen inside the agency as part and parcel of that quality push, a statement that seems to suggest that the FDA’s expectations regarding device manufacturing will be more stringent going forward.
