Advocacy - Lab Advocate
On October 7, the Food and Drug Administration (FDA) released final guidance to assist manufacturers who are developing 510(k) submissions for blood glucose monitors. The agency issued two documents – the first, “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use,” for devices that will be used within healthcare settings and a second, “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use,” that will address devices used by individuals to monitor their glucose levels at home. These documents revised earlier draft guidance released by the agency in January 2014.
AACC and its members are most concerned with the prescription POC guidance. Traditionally, these devices were waived regardless of whether they were used by lay users in their home or healthcare professionals in a clinical setting. The 2014 draft guidance suggested changing this policy and categorizing BGMs used in care settings, such as hospitals, as moderate complexity. This modification would have required healthcare facilities to comply with more stringent personnel and quality control requirements. Many groups, including AACC, asserted that the proposed change would increase the regulatory burden and costs on providers without improving patient care.
In the recently released October 2016 final prescription POC guidance, the FDA appears to address some of the concerns expressed by AACC and the healthcare community. Although the agency continues to state that BGMs will generally “be categorized upon clearance as moderate complexity,” the FDA goes on to state that manufacturers can perform studies, as outlined in the document, which will permit them to file dual 510(k)/CLIA wavier submissions that would result in simultaneous decisions—thus putting in place a fast track mechanism for waiving BGM test systems.
The FDA has also modified how a healthcare professional would demonstrate the accuracy of a BGM in a professional setting. The new guidance requirements more closely align with the specifications outlined in the Clinical and Laboratory Standards Institute document POCT12-A3, Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities, which were developed by laboratory and industry experts. In the new guidance, the FDA states that labs should:
“demonstrate that 95% of all values are within +/- 12% of the comparator method for glucose concentrations, > 75 mg/dL, and within +/- 12 mg/dL at glucose concentrations < 75 mg/dL, and 98% of values should be within +/- 15% of the comparator method for glucose concentrations >75 mg/dL, and within +/- 15 mg/dL at glucose concentrations < 75 mg/dL.”
Many AACC experts find this approach more pragmatic and reasonable than the approach outlined in the 2014 draft. AACC is continuing to review the document and evaluate the changes made by the FDA.
The FDA is planning a free webinar on the BGM guidance documents for November 21, 2016, from 11:00 am – 12:30 pm Eastern Time. Please visit the agency website instructions. Preregistration is not required to participate.