US Senators Lay Out Concerns On FDA Digital Health Device Precertification Program
Three senators led by Democrat Elizabeth Warren of Massachusetts on 30 October asked the Food and Drug Administration to answer a series of questions about its precertification pilot program for digital devices.
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2020 Outlook: US Congress Will Address Surprise Billing, Ratify USMCA, Conduct More Medtech Safety Oversight
Congress was able to approve a permanent medical device tax repeal and pass a “LAB Act” bill favorable to the diagnostic industry in 2019. But what device-related legislation is ahead in 2020? Medtech Insight takes a look at some of the medtech bills and draft legislation likely to affect manufacturers pending in late 2019 that are likely to be reviewed – and perhaps approved – in 2020.
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.
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.