FDA Issues Draft Guidance for Makers of Blood Glucose Meters

Miriam E. Tucker

November 30, 2018

The US Food and Drug Administration (FDA) is revising its guidance to industry for obtaining clearance for blood glucose monitors, with separate recommendations for devices to be used in the home and healthcare settings. 

The two documents, currently in draft form, were posted on the agency's website yesterday.

Once finalized, the documents will update two previous guidances issued in 2016. Both describe studies and information that the FDA recommends manufacturers use when preparing to submit premarket notifications, or "510(k)s," for blood glucose monitors.

One guidance addresses blood glucose monitoring systems for point-of-care use in healthcare facilities, the other for self-monitoring blood glucose (SMBG) test systems for over-the-counter home use by lay users.

The changes from the October 2016 final guidances are minimal but might be useful for clarification on some issues, including revising interferent concentration levels and hematocrit tests. This, the FDA notes, offers another opportunity to comment on the requirements for getting 510(k) clearance for these devices. 

"Today’s action is part of the FDA's continuing efforts to improve the development of new blood glucose meters based on feedback from both patients and health care providers, especially on the usability of glucose monitors," the agency writes in a statement.

According to FDA Commissioner Scott Gottlieb, MD, "It’s critical that patients with diabetes have access to blood glucose monitors that are safe, accurate, and easy to use. That's why the FDA has been modernizing our recommendations for the design and performance of these devices." 

Glucose Monitors Previously Evaluated for Home Use

Fewer conventional blood glucose monitors — as opposed to continuous glucose monitors (CGMs) — have been approved in recent years, with a shift to issues surrounding supplementary products, such as apps, rather than the devices themselves.

Most blood glucose meters on the market today were cleared by the FDA for over-the-counter home use by lay users and were never evaluated in healthcare settings such as physician offices, hospitals, assisted living facilities, and nursing homes.

This has raised concern that patients who are acutely ill or medically fragile might present physiologic or pathologic factors that could interfere with glucose measurements relative to lay users, the FDA document notes. 

"Therefore, when devices are intended for use in professional healthcare settings, the intended use population should be accurately defined, distinct performance parameters should be met, and sponsors should demonstrate substantial equivalence of the device for that particular use," the draft guidance indicates.

Manufacturers are not expected to seek clearance for use of their devices  across all professional healthcare settings.

However, "in all cases, performance studies should account for factors such as disease state, patient condition, physiological state, and medications that might affect device performance in the intended use population for that [blood glucose monitoring system]."

While blood glucose monitoring systems approved for use in healthcare settings would be considered moderate-complexity, the FDA advises manufacturers to include applications for Clinical Laboratory Improvement Amendments (CLIA) waivers along with their 510(k) submissions.

Both guidance documents also address infection control, along with performance standards for both meters and test strips.

For SMBG devices, the FDA observes that "the term lay-user encompasses a group of individuals with wide ranges in age, dexterity, vision, training received on performing testing, and other factors" that can be critical to the patient's ability to accurately use the device and interpret test results.

By making this distinction, SMBGs can be better designed to meet the needs of their intended use populations, thereby providing greater safety and efficacy, according to the agency.

Comments on the draft guidances are being accepted until February 28, 2019, and can be submitted with docket numbers FDA-2013-D-1445 (healthcare facility) and FDA-2013-D-1446 (over-the-counter).

The draft guidances for healthcare and for home use were posted on the FDA website on November 29, 2018.

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