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Latest From Sue Darcey
The US Congress this week agreed to keep the FDA and other government agencies funded at fiscal-year 2019 levels, extending the continuing resolution another four weeks until 20 December.
Hahn Fields Queries On Electrical Stim Devices, Molybdenum Supplies For Imaging At FDA Confirmation Hearing
MD Anderson Cancer Center chief medical officer Stephen Hahn fielded a number of questions senators asked at his 20 November confirmation hearing to lead the US FDA. Chief among them were inquiries about his government experience level, whether he would expedite a ban on electrical stimulation devices used against the intellectually disabled, and how he would address a shortage of molybdenum-99 used in advanced imaging scans.
CMS Hospital Price Transparency Rule To Begin Public Reveal Of Device-Related Procedure Prices, Test Costs In 2021
The US Medicare agency on 15 November released a final cost transparency rule calling on hospitals to detail their standard “shoppable services” charges for X-rays, advanced imaging, laboratory tests and an array of other device-related procedures, beginning on 1 January 2021. Meanwhile, an accompanying proposed rule released by the CMS on the same day would require insurance health plans to provide to participants and beneficiaries the insurers’ negotiated rates for all covered health-care items and services.
The US FDA cleared Pentax Medical’s new duodenoscope as the first in the US with a disposable elevator part that reduces the number of parts needed to be disinfected compared to earlier designs.
FDA Advisory Panel Debates Science On Human Adverse Biological Reactions To Metal-Containing Devices
US FDA scientists and immunological experts discussed the latest science regarding patients’ biological reactions to metal implants and mercury in dental amalgam at a 13-14 November agency advisory committee meeting. The get-together was held to determine what additional actions the FDA can take to make sure certain patients are protected from immunological risks of the implants. The panel ultimately backed a transition away from mercury amalgam dental fillings and pushed for more research into risks associated with metal implants.
US Democratic Sens. Elizabeth Warren of Massachusetts and Patty Murray of Washington State recently sent a letter to FDA officials Brett Giroir and Jeff Shuren that raises doubts about a planned bill calling for a progressive approval pathway for medical devices.