Posted 09 April 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) has announced that it will extend the comment period for two recently released draft guidance documents intended to help the medical device industry to develop blood glucose monitoring devices intended for both home and point-of-care use.
FDA's duo of draft guidances, released in January 2014, called for a new regulatory approach toward blood glucose test systems based on their location of use.
Regulators cited the differences in knowledge between a trained medical professional and an untrained layperson. The former is "generally more proficient at performing testing and at running appropriate controls, and they typically have a better understanding of test limitations as compared to laypersons," FDA said. Laypersons, by contrast, are less likely to possess those qualities and may be unable to appropriately use the device or correctly interpret data generated by it.
In addition, devices subject to real-world use conditions may need to be more "robust and reliable" than their more carefully used clinical counterparts.
These differences and others necessitated more nuanced approaches toward the testing and development of products, FDA said.
For Focus' thorough write-up on the two guidance documents, please see our January 2014 posting, "FDA Calls for New Development Approaches for Diabetes Testing Systems."
Comment Period Extended
But in response to comments from the medical device industry, FDA is placing the development and finalization of the guidance documents on hold-at least for now.
In a duo of Federal Register documents released on 9 April 2014, FDA said it would extend the comment period for each document for another two months. While the original comment period was to end on 7 April 2014, companies (and the public) now have until 7 May 2014 to weigh in on the documents.
FDA said the added time would help it in "identifying issues to be addressed in the finalized guidance document."
FDA has already received 152 comments on its point-of-care use guidance, and 263 comments on its over-the-counter use guidance as of 9 April 2014.
Federal Register Notices: (1) (2)