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Home » Authors » Mark McCarty

Articles by Mark McCarty

Gavel and FTC logo

Attorney predicts ‘all-out battle’ over FTC noncompete rule

April 24, 2024
By Mark McCarty
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.
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China in red on globe

Royal Philips hit with FDA warning over facility in China

April 23, 2024
By Mark McCarty
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.
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3D map of China

China’s NMPA may expect domestic HFE work for imported devices

April 23, 2024
By Mark McCarty
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.
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Gears with regulatory words
MDMA Annual Meeting

UK considering mutual recognition for FDA device reviews

April 19, 2024
By Mark McCarty
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.
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Black and white arrows merging into one
MDMA Annual Meeting

Compliance concerns driving more due diligence in med-tech M&As

April 19, 2024
By Mark McCarty
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.
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Gavel and FTC logo

Member of US House blasts FTC/DOJ merger guidelines

April 18, 2024
By Mark McCarty
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.
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Laptop displaying FDA logo
MDMA Annual Meeting

FDA’s Shuren calls for an end to the debate over LDT accuracy

April 18, 2024
By Mark McCarty
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.
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Artificial intelligence and digital health icons
MDMA Annual Meeting

Cassidy sees risk of hurried US legislation for AI

April 18, 2024
By Mark McCarty
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.
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Cloud/cybersecurity illustration

US House hearing includes calls for federal cybersecurity support

April 17, 2024
By Mark McCarty
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.”
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Gavel and FTC logo

Member of US House blasts FTC/DOJ merger guidelines

April 17, 2024
By Mark McCarty
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. Rep. Roger Williams (R-Texas) said the guidelines fail to account for the importance of these transactions for small businesses seeking to grow and requested that the two agencies provide data that would demonstrate whether such concerns were considered in drafting those rules.
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