The US Food and Drug Administration (US FDA) and US Department of Health and Human Sciences released today two draft guidances for blood glucose monitoring test systems (BGMSs).
While one is for prescription-use blood glucose meters, for use in point-of-care professional healthcare settings, the second guidance deals with blood glucose devices purchased over-the-counter, intended for self-monitoring by lay-persons.
This draft guidance document describes studies and criteria FDA recommends for BGMSs regarding labeling, meter performance evaluation, manufacturing controls, and cleaning and disinfection procedures to help improve their accuracy and performance.
When finalised, the US FDA intends for this document to guide manufacturers in conducting appropriate performance studies and preparing premarket notifications for these device types.
Industry can send in their comments on the guidances for the next 90 days (till April 7) after which the US FDA will begins work on the final version of the guidance.
EH News Bureau