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Home » FDA

Articles Tagged with ''FDA''

FDA’s final guidance for device software functions tightens requirements for anomalies

Aug. 9, 2023
By Mark McCarty
The U.S. FDA’s final guidance for premarket submissions for device software functions serves as a much needed overwrite of a badly outdated policy but includes some significant changes over the legacy guidance. There are also a few changes between the 2021 draft and the 2023 final guidance, however, such as a call for more details about how software anomalies were discovered and what a root cause analysis would suggest about the origin of the anomaly.
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US debate over Medicare coverage of novel technologies reaches JAMA

Aug. 8, 2023
By Mark McCarty
The debate in the U.S. over the process by which the Medicare program covers new medical technologies has intensified over the past three years and the debate has now spilled onto the pages of the Journal of the American Medical Association. An article in JAMA asserts that only 44% of a group of 64 novel devices had achieved meaningful coverage and reimbursement milestones within a median of 5.7 years after FDA market authorization, adding yet more pressure on the legislative and executive branches to act to deal with what device makers characterize as the med-tech valley of death.
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FDA breathes life into Etiometry’s algorithm for neonatal hypercapnia risk

Aug. 3, 2023
By Meg Bryant
Premature babies face challenges in the neonatal intensive care unit (NICU) as their heart, lungs and neurological system continue to develop outside the womb. Roughly half of neonates born at 26 weeks to 28 weeks gestation experience respiratory distress. These infants often need extra oxygen and help breathing, as well as constant monitoring to ensure oxygen is absorbed and carbon dioxide (CO2) is dispelled. To that end, Etiometry Inc. received FDA clearance for its IVCO2 Index, a software tool for use in monitoring risk of hypercapnia in NICU patients weighing less than 2 kg.
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US FDA’s proposal to reorganize Office of Regulatory Affairs not without pitfalls

Aug. 1, 2023
By Mark McCarty
The U.S. FDA unveiled a proposal to once again reshuffle its operations, this time with a greater degree of emphasis on the function of the Office of Regulatory Affairs (ORA). Tim Philips, a consultant with Gardner Law and a former member of the FDA, told BioWorld that while these changes will likely yield some useful efficiencies, they might also dilute some of the more useful interaction between industry and FDA, a loss that may be keenly felt when it comes to matters such as FDA inspections.
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FDA announces recall of Abbott Amplatzer sheath, correction for Abiomed Impella

July 28, 2023
By Mark McCarty
During the week of July 24, 2023, the FDA published several notifications of potentially elevated risks associated with medical devices, including a recall of a delivery sheath for the Amplatzer device by Abbott Laboratories. The agency also announced that Abiomed Inc. will provide a correction for the instructions for use (IFUs) for the Impella because of an issue seen when implanting the left ventricular assist device in patients with transcatheter aortic valve replacement (TAVR) devices.
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After yearlong break, OPDP sends new letter

June 16, 2023
By Mari Serebrov
In its first untitled letter in more than a year, the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) took Xeris Biopharma Holdings Inc. to task for two webpages promoting the company’s Recorlev.
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VRBPAC recommends monovalent vaccines targeting XBB for 2023-2024 COVID-19 campaign

June 16, 2023
The U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend COVID-19 vaccines for the 2023-2024 vaccination campaign be monovalent vaccines that target the XBB variants, currently the most prominent variants of the SARS-CoV-2 virus.
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Empty prescription drug bottle

Regulatory policies – solution or culprit in US drug shortages?

June 14, 2023
By Mari Serebrov
As new and ongoing drug shortages in the U.S. limit patients’ access to essential medicines and life-saving cancer treatments, the blame largely has fallen on increased demand, quality problems, the supply chain and lack of transparency in that chain.
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ASCO 2023: Accelerated approvals are both hero and obstacle

June 7, 2023
By Lee Landenberger
Since accelerated approvals first began to be granted in 1992, their pace for cancer indications has increased dramatically but a revolution in science has made it tough for the U.S. FDA to find its balance.
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3D illustration of transparent human torso with close up of spinal cord

Locate Bio receives breakthrough nod for Ldgraft spine fusion system

May 25, 2023
By Nuala Moran
The U.S. FDA has awarded Locate Bio Ltd. a breakthrough device designation for its Ldgraft spine fusion product for the treatment of degenerative disk disease, paving the way to the first in human study later this year.
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