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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

U.S. FDA headquarters

FDA wary of impact of retirements on inspectional activities

May 1, 2024
By Mark McCarty
The U.S. FDA’s senior managers often lament the lack of routine increases in taxpayer funding, a concern that Michael Rogers, the associate FDA commissioner for regulatory affairs, reiterated during a May 1 webinar. Rogers said the agency’s field inspectorate will be working through a large number of retirements over the next few years, a predicament he said will continue to be “a huge challenge” to overcome.
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Medicare puzzle

US Medicare may tighten coverage for leg, foot ulcer treatments

April 30, 2024
By Mark McCarty
U.S. Medicare coverage of products for leg and foot ulcers has undergone a second review in less than a year thanks to pushback from stakeholders after the August 2023 issuance of proposed non-coverage policies for more than 100 cell and tissue-based products.
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Man sleeping with CPAP machine

Philips eliminates overhang with $1.1B CPAP settlement

April 30, 2024
By Mark McCarty
Royal Philips NV has come to terms over class-action litigation in which plaintiffs alleged that particulate matter in continuous positive airway pressure (CPAP) machines has proven harmful to their health, bringing the matter to a $1.1 billion conclusion. Despite the 10-figure sum, news of the April 29 settlement sent the company’s share prices up by roughly a third in early morning trading, suggesting that investors had already baked their expectations of the settlement into their thinking about the company’s future.
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Purple-tinted test tubes and dropper

Final LDT rule likely to favor larger players in lab space

April 29, 2024
By Mark McCarty
The U.S. FDA’s final rule for regulation of lab-developed tests was hardly a shock to the world of regulation, but the final rule might provide a shock for sorts for smaller entities in the diagnostics space. Analysts with Leerink Partners said most companies they routinely track are unlikely to be immediately affected by the final rule, but noted that FDA regulation might make it tougher for smaller, new entries to the space to get to market.
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US flag, shopping cart of vials

FDA’s final LDT rule prompts more calls for passage of VALID Act

April 29, 2024
By Mark McCarty
The U.S. FDA has posted the long-awaited final rule for lab-developed tests, which amends the draft rule in a few key respects, but Reps. Diana DeGette and Larry Buchson, once again voiced their opposition to the rule. DeGette and Bucshon acknowledged that congressional inaction has left the FDA with few choices, but called again for passage of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which they said is critical because “burdensome regulation of these medical products creates uncertainty in the future of innovation and patient care.”
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Woman using VR headset

US FDA’s device center launches home health care initiative

April 25, 2024
By Mark McCarty
The U.S. FDA’s device center launched a new health care program designed to provide patients with a seamless home health care environment that stitches together various health care functions into an integrated system that eases the patient’s use of such technologies. The initiative, part of the agency’s health equity agenda, will rely on augmented and virtual reality and requires the development of a prototype that will be rolled out in underserved areas with several overarching objectives, including the democratization of clinical trial participation.
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Chinese flag on flagpole

EU takes aim at China’s med tech anticompetitive practices

April 24, 2024
By Mark McCarty
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.
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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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View All Articles by Mark McCarty

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