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Home » Authors » Mark McCarty

Articles by Mark McCarty

Architectural pillars

Edwards comes up short in US case testing Hatch-Waxman safe harbor

April 11, 2024
By Mark McCarty
The Hatch-Waxman Act provides a safe harbor that allows importation of an FDA-regulated article that would otherwise be deemed a case of patent infringement so long as the importation is for purposes reasonably related to obtaining regulatory approval. Edwards Lifesciences Corp. sued Meril Life Sciences Pvt Ltd. for importation of heart valves in a manner that Edwards argued was infringement under Hatch-Waxman, but while the Federal Circuit ruled 2-1 against Edwards, the dissenting opinion recommended an appeal to a full 12-judge panel that could reverse this outcome.
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Flag of Australia, sky background

TGA eyes guidance on regulatory status of CDS software

April 10, 2024
By Mark McCarty
Australia’s Therapeutic Goods Administration decided to take another look at the regulatory definition of the clinical decision support (CDS) system, a move driven by technological advances and some confusion as to what type of CDS is exempt from registration requirements.
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Phillips Recall Mask BiPAP CPAP

Philips hit with consent decree over CPAP foam materials

April 10, 2024
By Mark McCarty
The U.S. FDA and Department of Justice have announced a consent decree entered into district court that enjoins Philips Respironics LLC North America from manufacturing and distributing respiratory devices from three company facilities in the state of Pennsylvania.
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Regulatory icons

ANVISA to consider other regulatory decisions for device registration

April 9, 2024
By Mark McCarty
While the notion of a medical device single review program is still more aspirational than respirational, a number of nations are shifting incrementally toward mutual recognition for medical devices.
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FDA icons and doctor

Attorney says wound dressings in ‘dire circumstances’ under FDA draft rule

April 9, 2024
By Mark McCarty
The U.S. FDA proposed in November 2023 to up-classify many wound care products that are associated with antimicrobial resistance, a change that would require a large number of clinical trials and a large volume of new premarket applications for the agency.
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Product recall concept image

J&J’s Medos withdrawing neurovascular guide catheters

April 8, 2024
By Mark McCarty
The U.S. FDA announced a class I recall of single-use neurovascular guide catheters made by Medos International Sarl SA of Neuchatel, Switzerland, because of fractures in the device’s distal catheter shaft. The FDA stated that the issue, seen in the company’s Cerebase DA line of guide sheaths, has led Medos to recommend that customers quarantine any of the affected devices, although a root cause has not yet been identified.
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Gavel and FTC logo

USTR’s Tai sees state champions as anticompetitive policy instruments

April 8, 2024
By Mark McCarty
Life science companies and the Office of the U.S. Trade Representative have not always seen eye to eye on issues such as compulsory licensing, but industry might be supportive of a remark by U.S. Trade Representative Katherine Tai about companies that are provided with anticompetitive breathing by their host governments with noticeable anticompetitive effect. 
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FDA sign

US FDA, Renovo at loggerheads over added sterilization inventory

April 5, 2024
By Mark McCarty
Some warning letters issued by the U.S. FDA are fairly simple matters, but that statement does not appear to apply to the Oct. 13, 2023, warning letter to Renovo Inc., of Bend, Ore. The warning letter provided a laundry list of sterilized reusable devices the agency said were not properly validated for sterilization, but the company rebutted these allegations in a vigorous defense of its reputation as a reprocessor.
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Beckman Coulter, Agena hit with recent FDA warnings

April 4, 2024
By Mark McCarty
The U.S. FDA posted two device warning letters in the first week of April 2024, including one each to Beckman Coulter Inc., of Brea, Calif., and Agena Bioscience Inc. of San Diego, the former of which was directed toward the Chaska, Minn., facility that manufactures the Beckman Coulter Dxl 9000 analyzer.
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Cyber security padlock

US cybersecurity rule may increase device reporting requirements

April 3, 2024
By Mark McCarty
Makers of medical devices already have a substantial series of requirements related to cybersecurity, but those requirements may increase per a draft rule released by the U.S. Cybersecurity and Infrastructure Security Agency.
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