The U.S. Food and Drug Administration has issued draft guidance distinguishing between prescription blood glucose meters intended for use in point-of-care professional healthcare settings and over-the-counter blood glucose meters for consumers. The document was published on Jan. 7 in the Federal Register for public comment.
"Historically, the FDA has not recommended different types of information in premarket submissions (510(k)s) for blood glucose meters used by medical professionals as compared to over-the-counter self-monitoring devices intended for use by lay users," states the draft FDA guidance. "However, it has become increasingly clear that these different use settings create distinct intended use populations with unique characteristics and device design requirements…The FDA believes that in making this distinction, each of the devices can be better designed to meet the needs of their intended use populations, thereby ensuring greater safety and efficacy."
According to the regulatory agency, concerns have been raised about infection control issues related to point-of-care glucose meters as well as the inability of currently cleared blood glucose monitoring test systems (BGMSs) to perform effectively in professional healthcare settings because the device's safety and effectiveness have not been evaluated for some of the intended use populations.
"In the last 10 years there has been much advancement in the development of glucose meters. They are now smaller, require a smaller blood sample for each test and produce faster results. However, their accuracy has improved little," writes Courtney Lias, Director of the Division of Chemistry and Toxicology Devices within the Office of In Vitro Diagnostics and Radiological Devices at FDA's Center for Devices and Radiological Health, in a Jan. 9 blog post.
To address this problem, FDA has proposed new recommendations for labeling, meter performance evaluation, manufacturing controls, and cleaning and disinfection procedures to help improve the accuracy and performance of blood glucose meters. The draft guidance document also describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for BGMS devices which are for prescription point-of-care use. When finalized, the agency intends for this document to guide manufacturers in conducting appropriate performance studies and preparing premarket notifications for these types of devices.
"Generally, we consider glucose meters to be a moderate level of concern because glucose results will be the basis for treatment, including determination of insulin dosage by the patient or healthcare provider," states the draft FDA guidance. "Incorrect glucose results or failure of the software to detect an error could result in improper therapeutic management."
At a Nov. 19 congressional hearing examining federal regulation of mobile medical apps and other health software, Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, testified that the SOFTWARE Act, a bipartisan bill introduced in October to amend the Federal Food, Drug and Cosmetic Act and to limit FDA authority, "takes out from our authority the ability to assure the safety and effectiveness of devices that we currently regulate including some high risk devices" such as blood glucose meters.
Earlier this month, Fort Lauderdale-based Nipro Diagnostics announced a voluntary recall and replacement of its blood glucose meters.
"If a consumer were not to notice the incorrect unit of measure, it is possible that the meter result could be read as a lower than expected blood glucose result," states the Nipro Diagnostics announcement.
To learn more:
- read the draft guidance