FDA Issues Final Guidance For Prescription, Over-The-Counter Blood Glucose Meters

By Jof Enriquez,
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The U.S. Food and Drug Administration (FDA) has simultaneously issued two guidance documents to assist manufacturers in preparing 510(k) submissions for glucometers for prescription and over-the-counter (OTC) uses.

In the past, FDA has not made a distinction between prescription-use blood glucose meters used in point-of-care healthcare settings and those used for OTC self-monitoring by lay users. However, the Centers for Disease Control and Prevention (CDC) has found out that blood glucose meters in healthcare settings are more likely to be used in multiple patients, and pose a greater threat in transmitting deadly bloodborne pathogens because of inadequate infection control measures.  Scientific and clinical issues specific to the professional healthcare setting which could affect glucose meter performance were never evaluated for these devices, even if they were submitted to FDA for OTC home use also.

"It has become increasingly clear that these different use settings comprise distinct intended use populations with unique characteristics that can impact device design specifications, and that manufacturers should take these unique characteristics into account when designing their devices," states FDA.

The two separate guidance documents – Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use and Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use – both describe studies and criteria that FDA recommends could be used when submitting premarket notifications (510(k)s) for both types of devices. FDA intends for the documents to serve as guides for manufacturers in conducting appropriate performance studies and preparing 510(k)s for both types of glucometers, according to the Regulatory Affairs Professional Society (RAPS).

In the guidance for prescription BGMs, FDA devotes a chapter to recommendations for manufacturers on how to minimize the risk of bloodborne pathogen transmission through proper device design and labeling. FDA also identifies validated cleaning and disinfection procedures to follow, and recommends that manufacturers conduct bench studies to demonstrate that the BGM device is robust enough to withstand repeated cleaning and disinfection cycles. Sponsors also should include in their 510(k) submissions both within-run precision and intermediate precision studies, as well as flex studies, including test strip stability and short sample detection testing, among others.

The guidance for SMBGs contains similar recommendations. Compared to professional healthcare settings, however, FDA notes that there typically are fewer controls in place in home-use settings to mitigate the risk of erroneous results.

"It is therefore assumed that devices intended for home use by lay-users are designed so the risk of an erroneous result should be far less than with laboratory-based tests. You should therefore demonstrate that your SMBG design is robust (e.g., insensitive to environmental and usage variation) and that all known sources of error have been assessed through a detailed risk assessment and are effectively controlled," states FDA.

For both types of glucose meters, regardless of intended use, FDA says manufacturers should stress, on device labels, the risk of disease transmission. Prescription BGMs user manuals should contain detailed instructions for users on how to perform cleaning and disinfection procedures for the meter between patients. OTC SMBGs, meanwhile, should contain a warning that the meter and lancing device is for single patient use only.