The FDA has released a proposed rule to clarify the kind of evidence it will consider relevant when determining the intended uses of a medical product. Among the types of evidence the agency considers relevant include implied claims, express claims and representations, product designs and characteristics, and the circumstances of distribution or sale.
A premarket approval supplement application has been submitted by Becton Dickinson to the FDA to allow use of the company's ThinPrep Pap Test PreservCyt Solution vial with its BD Onclarity HPV Assay.
Research published in JAMA Network Open shows that a routine blood test for red cell distribution width could be used as a potential indicator of a COVID-19 patient's risk for severe illness and death. Patients who had levels above the normal range were nearly three times as likely to die from the disease.
The FDA has given 510(k) clearance to NOUS Imaging for its Framewise Integrated Real-Time MRI Monitoring software that calculates patient motion during MRI head scans.
President Donald Trump said he's looking at reports that the FDA plans to implement stricter emergency use authorization standards for potential COVID-19 vaccines, noting the administration "may or may not approve" the changes.
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