FDA Finalizes Guidance On Blood Glucose Meters With Separate Documents For OTC, Rx Devices
Executive Summary
The documents issued by the US agency on 29 September set slightly different accuracy standards, reflecting the increased fragility of hospital patients.
You may also be interested in...
US FDA Redrafts Glucose Meter Guidances With Small Updates
The agency finalized two parallel guidance documents in 2016 relating to hospital point-of-care and patient over-the-counter use of blood glucose meters. But it has now reissued the documents in draft form to make what an agency spokeswoman referred to as "mostly minor" changes.
Addition to Quest Alzheimer's Suite Looks For Biomarker P-Tau217
The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.