The EU has declared that it will investigate the anticompetitive practices of the People’s Republic of China where medical devices are concerned, a clear sign that device makers in the European Union succeeded in persuading Brussels that the Made in China 2025 initiative represents an intolerable form of economic adversarialism.

The U.S. Federal Trade Commission’s final rule for noncompete clauses in employment contracts would seem to endanger life science patents and trade secrets, but there is a question of whether the agency stepped outside its statutory bounds in forming the rule. The U.S. Chamber of Commerce has already filed suit on the rule, but Joshua Rich of McDonnell Boehnen Hulbert & Berghoff LLP told BioWorld, that the Chamber is unlikely to be the last entity to file suit over the rule.

Royal Philips NV may feel it has had enough recent interaction with the U.S. FDA, but the company is now in receipt of a warning letter from the agency over a facility located in Suzhou, China. The FDA was none too fond of the facility’s handling of a contract manufactured data cable used in CT systems because of malfunctions that may have delayed diagnostic imaging procedures, representing yet another regulatory distraction for a company that recently cleared a long-running conflict with the FDA over CPAP machines.

China’s National Medical Products Administration (NMPA) has issued a guidance for human factors engineering (HFE) of medical devices, a document that by some accounts aligns fairly well with guidance from the U.S. FDA. However, Yvonne Limpens, manager of the human factors program at Emergo by UL, said NMPA may push for domestic HFE testing on imported devices because of a perception that device usability may be different in China than in other nations, thus adding to the cost of doing business in the world’s second most populous nation.

Reliance may be the regulatory buzzword of the moment, but mutual recognition agreements between regulators are much more near and dear to the hearts of device makers. Richard Phillips, director of strategy for Association of British Health Tech Industries Ltd., told an audience of device makers that the U.K. is considering recognition of devices approved and cleared by the FDA, although Phillips said such recognition for 510(k) devices might be less than a simple exercise.

Companies that buy other companies know perfectly well that they may acquire a few headaches in the process, but recent enforcement trends are making the acquiring companies more careful about acquisitions. Regulatory attorney Jennifer Bragg told an audience at this year’s meeting of the Medical Device Manufacturers Association (MDMA) that the smarter companies are doing their due diligence before approaching the target company, an exercise that could ultimately dissuade the would-be acquirer of the wisdom of the transaction.

The new merger guidelines released by the U.S. Department of Justice and the Federal Trade Commission have proven controversial on several fronts, but now the House of Representatives is weighing in.

While the U.S. FDA’s final rule for regulation of lab-developed tests (LDTs) has yet to emerge, there is some reason to expect the rule will be met with litigation from clinical lab associations. The FDA’s Jeff Shuren said in remarks to this year’s meeting of the Medical Device Manufacturers Association that there is a legitimate problem with the accuracy of many LDTs, adding that while stakeholders are at liberty to question the FDA’s rulemaking, the agency’s experience in this area indicates that the question of LDT reliability is not up for debate.

One of the problems with the European Union’s Artificial Intelligence Act is that it spans all sectors of the E.U. economy, an approach that Sen. Bill Cassidy (R-La.) suggested is less than optimal in remarks to this year’s meeting of the Medical Device Manufacturers Association. Nonetheless, Cassidy said some in the Senate are keen to pass legislation without taking proper stock of the lack of congressional expertise, which runs the risk that hasty legislation may create more problems than it solves.

With the recent hack of Change Healthcare back in the news, a committee of the U.S. House of Representatives took up the subject of cybersecurity, which included only a couple of mentions of medical devices. However, witnesses at the hearing emphasized the role of the federal government in thwarting foreign cybersecurity threats against health care facilities, with John Riggi of the American Hospital Association stating, “we need the [federal] government to go after bad actors overseas.”