FDA Reissues Two Draft Guidances on Blood Glucose Monitoring Test Systems

Regulatory NewsRegulatory News | 29 November 2018 |  By 

The US Food and Drug Administration (FDA) on Thursday reissued two draft guidances to help manufacturers conduct performance studies on blood glucose monitoring test systems (BGMS) for point of care (POC) and over-the-counter (OTC) use and prepare 510(k) submissions for both device types.

Both draft guidances propose changes to 2016 final guidances “based on feedback from stakeholders requesting more clarification on language,” FDA spokesperson Jennifer Rodriguez said on Thursday. The agency received 187 and 390 comments on the POC and OTC guidances, respectively.

Some of the changes to the revised documents simply tweaked the wording used for certain recommendations, such as to clarify that their prescription and accuracy evaluation scenarios “are provided only as examples,” while others introduce policy clarifications that allow for greater flexibility.

The revised versions nixed some of the 2016-specified measures when designing clinical studies to instead leave it up to each sponsor to make BGMS-specific determinations on what is “necessary.”

Other changes proposed in the draft guidances relate to the FDA-recommended confidence intervals for data on meters’ summary of results and the appropriate concentration of acetaminophen. Confidence intervals should be at 95%, compared to 99% in 2016. The highest concentration of acetaminophen should be no more than 5 mg/dL versus the 2016 approach using the lowest concentration of 10 mg/dL.

The policy clarifications further emphasize the need for sponsors to ensure a BGMS glucose value is “as reliable as possible” to “robustly” assess its accuracy as well as determine bias, with new policies under the revamped data analysis sections on estimation of bias to comparator methods and due to hematocrit. Tables on estimation of bias were retained from 2016 and fleshed out with additional examples.

In addition to the data analysis sections, both drafts include a revised list of known or potential interferants for BGMSs. Revisions involve replacing icodextrin with mannitol (1800 mg/dL) and 16 updated recommendations on test concentrations, including hemoglobin and heparin, among others.

Yet another revised recommendation involves test strip stability testing. The new draft guidances decreased the number of studies recommended to assess test strip performance from three in 2016 to two, including shelf life and open vial stability. Extended open vial studies are not recommended.

The policy updates come at a time when demand of BGMS is expected to increase globally partly due to technological advancements, such as sensors powered by artificial intelligence. They underscore recent trends in the US health care system around remote patient monitoring and aging in place.  

The move is “part of the FDA’s continuing efforts to improve development of new meters based on feedback from both patients and providers,” FDA Commissioner Scott Gottlieb said. The agency is “committed to improving the safety and performance of medical devices, including blood glucose monitors, and to taking steps to help make sure that products continually incorporate new technology that can improve safety and better meet the needs of patients and providers,” he added.

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use: Draft Guidance

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use: Draft Guidance


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy