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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

FDA approved icons and medical professional

FDA drops three draft guidances for 510(k)s, including a predicate best practices draft

Sep. 6, 2023
By Mark McCarty
The U.S. FDA’s concerns about the 510(k) program over the past decade-plus are practically the stuff of regulatory urban legend, but the agency has just unveiled a trio of draft guidances to address some of those concerns. Perhaps the most significant of these is a draft guidance for selection of a predicate device for a 510(k) filing, a document that may come across to industry as little more than an attempt to limit the devices that a manufacturer can recite in a 510(k) filing.
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FDA sees lack of alternatives for Datascope balloon pumps despite recalls

Sep. 5, 2023
By Mark McCarty
The U.S. FDA recently posted another round of recalls for the Cardiosave line of intra-aortic balloon pumps (IABPs) by Datascope Corp., advising users to make sure they have a backup unit at the ready in the case of device failure. However, the agency noted that “alternative treatments are limited,” a clear sign that this market lacks competition, most likely due to a lack of incentives for the private sector to invest in this class of devices.
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U.S. flag, stethoscope

Med-tech industry nominally supportive of TCET, but urges Medicare agency to expand scope

Sep. 5, 2023
By Mark McCarty

The proposed U.S. Medicare framework titled Transitional Coverage for Emerging Technologies (TCET) promises to expand on existing mechanisms for Medicare device coverage, but industry has serious misgivings about the proposal.


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Fraud blocks under magnifying glass

US DOJ announces two new field offices for COVID fraud enforcement

Aug. 25, 2023
By Mark McCarty
The U.S. Department of Justice (DOJ) has been aggressively pursuing fraud perpetrated on the American public in connection with the COVID-19 pandemic, but the formal end of the U.S. public health emergency might seem to suggest that these efforts would be winding down. Nonetheless, deputy attorney general Lisa Monaco has announced that DOJ will open two new strike force offices under the agency’s COVID fraud operations, making clear that the agency is still intent on chasing down fraudsters across the U.S.
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Medtronic - Symplicty Spyral HTN

Divergent trial results tank Medtronic’s Symplicity Spyral at FDA advisory

Aug. 24, 2023
By Mark McCarty
Dublin-based Medtronic plc. has invested considerable resources into its renal denervation program, but the company has not completed its regulatory journey for the U.S. market just yet. Medtronic failed to persuade an FDA advisory committee of the virtues of its Symplicity Spyral device due to inconsistent results from the two major studies presented at the hearing but vowed to keep working on the application despite the sustained headwinds.
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US FTC taps Covington’s Liu for director of Bureau of Competition

Aug. 23, 2023
By Mark McCarty
The U.S. Federal Trade Commission has picked Henry Liu of the law firm of Covington & Burling to run the agency’s Bureau of Competition, a seat that was vacated earlier this year when Holly Vedova retired.
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Recor Medicaal Paradise renal denervation catheter

Recor snares supportive vote from FDA advisory panel for Paradise renal denervation device

Aug. 23, 2023
By Mark McCarty
The age of renal denervation as a treatment for hypertension may have finally arrived in the U.S. with the affirmative U.S. FDA advisory vote for the Paradise system for renal denervation by Recor Medical Inc., of Palo Alto, Calif. The 12-member advisory committee vote unanimously that the data suggested the ultrasound-based device was safe and voted 8-3 in support of the Paradise’s efficacy, an outcome that the agency may find difficult to refute, given the large public health impact of hypertension in the U.S.
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Gavel and scales

US judicial advisory committee ponders streamlined rules for attorney-client privilege

Aug. 22, 2023
By Mark McCarty
The process of discovery is resource-consuming in any type of litigation, but this is especially the case for patent litigation due to the exceptional importance of attorney-client privilege in patent prosecution. However, a U.S. judicial advisory committee is considering a rewrite of the rules to ease some of this burden in a move that could cut both the expense and time consumed by patent litigation, a development that is sure to draw cheers from across the spectrum of innovators in the life sciences.
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Generic drugs and bottle

US FDA’s Califf says supply chain issues with generic drugs are a national security risk

Aug. 22, 2023
By Mark McCarty
The U.S. FDA is in the midst of a shake-up of several major offices, including the Office of Regulatory Affairs, but its commissioner, Robert Califf, believes there are even greater issues faced by the agency. Califf said during an Aug. 22 public forum that prices for generic drugs are too low to encourage manufacturers to continue to produce these products, adding that the issue is sufficiently severe to constitute a national security risk.
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Architectural pillars

Bard loses appeal of US lawsuit after judge in jury trial disallows evidence of 510(k)

Aug. 21, 2023
By Mark McCarty
U.S. federal preemption of state liability law for medical devices is firmly established for PMA devices, but this is not the case for devices that are cleared via the U.S. FDA‘s 510(k) program. However, some courts have gone a step further in disallowing defendants in product liability litigation from entering evidence of 510(k) clearances from the FDA, a practice that played a role in a $3.3 million verdict against Murray Hill, N.J.-based C.R. Bard Inc. that the U.S. Court of Appeals for the Seventh Circuit decreed is not eligible for a new trial.
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