The U.S. Office of Inspector General at HHS updated its FAQs Aug. 4 for enforcement during the COVID-19 pandemic, stating that the agency would not object to an arrangement in which a clinical lab provided free antibody testing for the SARS-CoV-2 virus to patients undergoing other testing at the lab. The unnamed petitioner indicated that it seeks to boost patient awareness of antibodies used to develop convalescent plasma, and the results of these tests could be obtained by the patient, the patient’s physician, and would be reported to federal data registries. This opinion assumes that the prescribing physician received nothing from the lab, and that the payer would not be billed for the test. Any such tests must have been approved or cleared by the FDA or authorized under the emergency use authorization program at the FDA.

The U.S. Preventive Services Task Force (USPSTF) affirmed its non-recommendation for screening for carotid artery stenosis for those who are both asymptomatic for stenosis and have no history of cerebral vascular events. This update reiterates the assessment conducted in 2014, which likewise found little evidence that screening with duplex ultrasound provided a net health benefit, although some of the studies captured for the earlier review mixed both symptomatic and asymptomatic patients. USPSTF is taking comment through Aug. 31, 2020.

The U.S. Federal Trade Commission (FTC) said it has filed suit against three entities that failed to deliver on promises to expeditiously ship personal protective equipment and hand sanitizer, said to be violations of the agency’s mail order rule. One of the entities named by the FTC printed shipping labels with the appropriate date, but often did not deliver the products to the post office “for weeks or months,” the statement indicates. The FTC said it files a complaint when it has reason to believe that defendants “are violating or are about to violate the law.”

The Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (Advamed) applauded new legislation by Reps. Jackie Walorski (R-Ind.) and Dean Phillips (D-Minn.) that would allow small device manufacturing companies to recover operating losses in an effort to sustain these companies in the pandemic. The Ignite American Innovation Act of 2020 (H.R. 7917) would allow C corporations with fewer than 1,500 employees to monetize up to $25 million in net operating loss carryforwards and research and development credits, which would counteract the fact that many small device and diagnostics companies operate in the red for several years after their founding. Mark Leahey, president and CEO of MDMA, said in an Aug. 5 statement that the pandemic “continues to cause severe disruptions for countless innovators who are simply trying to keep their doors open and retain their workforce.” Leahey said existing liquidity programs are difficult or impossible to access for many small entities because many small device makers are operating at a loss. "American med-tech innovation is driven by small companies and start-ups on the cutting edge of improving patient care. In the best of times, these heavily R&D-focused firms struggle to find the financing and resources they need to navigate tough regulatory and reimbursement pathways in order to bring a new device or diagnostic to market, and that challenge has been magnified by the pandemic,” said Ashley Wittorf, executive director, Advamed Accel & global head, investor relations, in an Aug. 5 statement. She added that the legislation “will serve as a vital lifeline to these small, entrepreneurial companies, allowing them to weather the current COVID-related economic downturn and continue developing the next-generation treatments and cures patients are waiting for."

The U.S. FDA said the class I recall of infusion sets for the Bodyguard infusion system is due to infusion rate errors for which the cause is unknown. CME America LLC, of Golden, Colo., is updating the recall, initially announced in April 2020, after testing of the infusion sets determined that the units failed to deliver infusion drugs within 5% of a system accuracy threshold or the 13% accuracy level identified in the previous recall. The recall affects six types of infusion sets distributed between May 2016 and May 2020, accounting for nearly 4.9 million units.

The U.S. FDA said it will hold four days of virtual training for accreditation bodies (ABs) that will take part in the agency’s accreditation scheme for conformity assessment (ASCA) program later this year. The agency recommended that ABs should attend all four days of training, which will take place Oct. 29-30 and Nov. 2-3, 2020. The ASCA program is designed to streamline the premarket process for medical devices by providing a non-FDA mechanism for establishing a device’s conformance with safety and performance standards.

No Comments