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FDA discounted potential risks when approving continuous glucose monitoring device, expert claims

BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1775 (Published 23 April 2018) Cite this as: BMJ 2018;361:k1775
  1. Martha Rosenberg
  1. Chicago, USA

The US Food and Drug Administration (FDA) has been accused of discounting up to 30 000 medical device reports (MDR) when, in 2016, it expanded the approved use of a continuous glucose monitoring system (CGM) to replace self monitoring.1

Alan Shapiro, clinical associate professor of medicine at New York University School of Medicine, and an expert in medical statistics, said the agency had not taken account of the findings from the reports when it made the decision to approve the Dexcom G5 mobile system.

CGMs use below-the-skin sensors that continuously measure glucose levels and wirelessly send the results to a receiver and a compatible mobile device.

Shapiro has highlighted, in several journal articles,23 that the MDRs from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) system showed substantial inaccuracies from the CGM device.

The FDA’s executive summary for the panel considering expanded use gave MDR data for the G5 and similar devices under …

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