FDA Finalizes Guidance On Blood Glucose Meters With Separate Documents For OTC, Rx Devices
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...
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.
The document recommends testing for blood biotin levels as high as 3500 ng/mL, three times the maximum expected clinical concentration.
The US Department of Justice says the company provided advertising assistance and educational grants to health care providers that used its embolization devices.