FDA Catches Heat For Plans To Raise Standards For Hospital Glucose Meters
This article was originally published in The Pink Sheet Daily
An FDA draft guidance issued earlier this year on hospital glucose meters has attracted an unusual amount of attention, including criticism from clinicians, companies and others who worry it could cut off access to point-of-care glucose testing in patient cases where it is needed
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Certain 510(k)-cleared blood glucose meters do not perform at the regulatory standards for which they were cleared after they hit the market, stakeholders agree. FDA is working on the matter, but no clear plan of action was laid out at a Diabetes Technology Society meeting last week.
Johnson & Johnson/LifeScan is exiting the hospital point-of-care blood glucose meter market in the U.S. and Canada to focus exclusively on consumer self-monitoring devices in the regions.
The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.