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.

The U.S. Department of Justice (DOJ) announced in May 2023 that it had obtained a judgment of more than $487 million against the parent company of Precision Lens for alleged violations of the False Claims Act (FCA), but the amount of that decision has been overturned. In a Feb. 8 decision, the U.S. District Court for the District of Minnesota decreed that the judgment be reduced to less than $217 million, an outcome which suggests that some of the more excessive fines levied against health care companies will be viewed with more skepticism upon appeal.

The U.S. FDA reported Feb. 15 that Philips USA, a subsidiary of Amsterdam-based Royal Philips NV, recalled three models of the Brightview line of single photon emission CT (SPECT) systems due to an incident in which the system detector fell.

The ongoing saga of the Environmental Protection Agency’s (EPA) pending rule on ethylene oxide (EtO) made its way to a Feb. 14 hearing in the U.S. House of Representatives, which included the testimony of Lishan Aklog of Pavmed Inc., who warned that a significant curtailment of EtO as a sterilant for medical devices could hamper patient access to medical devices.

The U.S. Securities and Exchange Commission (SEC) said Feb. 14 that it may elevate the threshold for registration of venture capital (VC) funds from $10 million to $12 million, a move that would exempt at least a few med-tech VC funds from registration requirements.

Body: The U.K.’s Medicines and Health Care Products Regulatory Agency (MHRA) has a program designed to facilitate more rapid market access for medical devices of urgent need, and now the agency has put money into the policy.

The U.S. FDA has posted information on the regulatory review period for several medical devices that incorporate patented inventions, such as the determination for the Simplify artificial cervical disc by Simplify Medical Inc., of Sunnyvale, Calif. According to the FDA, the company seeks to tack nearly 1,100 days back on to the patent in question, an additional three years that may play a significant role in the company’s attempt to monetize the patent in question.

The U.S. Patent and Trademark Office (PTO) has released a draft version of patent examiner guidelines to address the increasing use of artificial intelligence (AI) in the inventive process, reflecting the standing U.S. position that AI cannot be an inventor.

The U.S. FDA has released a draft guidance for the use of data monitoring committees (DMCs) for clinical trials for devices and drugs, which would overwrite a similar guidance from 2006. This new draft guidance explicitly states that clinical studies more commonly employ DMCs than was the case 18 years ago and would seem to suggest that the agency will more routinely require the use of DMCs than was common practice in the past.

The U.S. FDA recently convened an advisory hearing to review the agency’s list of essential items for public health emergencies and led the hearing with its own list to which the advisory committee recommended numerous additions. How the FDA will respond remains to be seen, but the FDA’s list may grow significantly larger despite that industry representatives advised that existing supply chain redundancies would seem to suggest that some devices and associated items need not be subject to FDA supply chain oversight.