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.”…