Monday, October 10, 2016

FDA Issues Long Awaited Final Guidances on Glucose Monitoring

For years, there have been complaints that the FDA was using outdated 1970s standards to clear glucose meters, and not revising the standards to keep up with best of breed newer technologies.  This means the US marketplace could be cluttered with low-performance meters.  (See here and here).  Some studies have modeled the adverse health events that are likely caused by marketable, but low-accuracy, blood glucose meters (here).   In response, the Diabetes Technology Society launched an effort, through surveillance and certification, to endorse high-performance meters that others had no special recognition by FDA (here for homepage, here for article).

For European regulators, ISO announced new, tighter blood glucose meter accuracy standards in 2013 (here).

In October 2016, the FDA has finalized two guidance documents for US blood glucose meter performance, one for devices sold over the counter, and one for use in prescription settings (e.g. hospitals).    The new 2016 guidance documents are here for prescription use, here for OTC use.  (The corresponding brief Federal Register announcements are here and here.)   The guidances are fairly lengthy, at over 40 pages each.

These guidances were issued in draft form, for comment, in 2014 (trade journal articles here and here).  At that time there was some kickback; for example, would tighter standards require more bulky and slow meter equipment (here)?  AdvaMed responded to the hospital device draft guidance with a 47 page critique (here); AACC posted a long article on the same topic here.   An analysis of comments is available here.

For an October 2016 article at RAPS, see here.

For an FDA deck on its BGM review process as of 2014, here.
The FDA pulls down draft guidances and puts up final guidance at the same weblink, but:
    For a cloud copy of the 2014 draft guidance for prescription (institutional) devices, here.
    For a cloud copy of the 2014 draft guidance for OTC (home) devices, here.
In other FDA diabetes news, in August 2016, the agency held a public workshop on the pathway to novel outcome measures; FDA website here, trade news here.  The FDA posts full video and will post a full transcript by November.