Regulatory Aspects of Invasive Glucose Measurements

Abstract

On May 26, 1976, the Food and Drug Administration (FDA) began implementing the Medical Device Amendments to the Federal Food Drug and Cosmetic Act. These amendments give FDA specific authority to regulate "medical devices." Additional authority was provided in the Safe Medical Devices Act of 1990. The pathways to get in vitro diagnostic products to market for commercial distribution include: premarket notification [or 510(k)] and premarket approval (PMA). Reviews of these applications are performed in the Division of Clinical Laboratory Devices, Office of Device Evaluation within the Center for Devices and Radiological Health. Most submissions for invasive glucose devices are 510(k) applications. Through this process the manufacturer demonstrates that its device is substantially equivalent to another device that is already legally marketed, referred to as the predicate device. To date, noninvasive and minimally invasive glucose testings have been approved through the PMA process and will be discussed in a separate article.

Assessing the Quality of Glucose Monitor Studies: A Critical Evaluation of Published Reports

“…The US Food and Drug Administration (FDA) 3 has cleared more than 200 glucose monitors for home and institutional use (2 ). To ascertain whether or not a monitor is acceptable for its intended use, the FDA carefully reviews clinical and laboratory evidence provided by the device manufacturer (3 ).…”

Glucose and Glycated Haemoglobin Point-of-care Testing and Early Diagnosis of Diabetes and Pre-diabetes

“…25 evidence provided by the manufacturer. 62,63 A systematic review in 2007 concluded that none of the included reports on the evaluation of glucose point-of-care devices followed generally accepted recommendations of performing these evaluation studies and the authors concluded that these limitations may have affected the conclusions of these evaluation reports. 64 The Clinical and Laboratory Standards Institute (CLSI)/National Committee on Clinical Laboratory Standards (NCCLS) guideline states that >95% of the results should be within ±20% or 0.8mmol/l (whichever is greater) of the laboratory value.…”