The end of the year is a time for reflection and maybe even gratitude, but as we can all testify, holiday shopping can be an irritating experience. The FDA got an early start on its holiday shopping list in the first week of December with the publication of several guidances as part of the overhaul of its approach to digital health. As might be expected, though, the experience is a decidedly mixed bag of items, one of which seems likely to be returned for exchange.
SaMD Final: A Leaner, Nicer Approach
On the positive side, the final guidance for software as a medical device (SaMD), the draft of which was written by the International Medical Device Regulators Forum, eliminates some of the seemingly compulsory tone of the draft. Nonetheless, the FDA went to some lengths to emphasize in the final that industry should not read too much into the use of words such as “requirements,” explaining that related provisions fall into the category of recommendations. Given the recent congressional emphasis on the least burdensome standard, the agency perhaps had little choice but to make such a conciliatory gesture.
The final SaMD guidance is 15 pages leaner than the draft (30 pages rather than 45), and large portions of the draft have either slimmed down or disappeared entirely. Definitions have become less descriptive, thus lending an unmistakable air of flexibility to the document. Whereas the draft commits page after page to discussions of generating evidence for scientific and analytical validity, the final guidance offers mere paragraphs for considerations such as analytical and technical validation.
The net effect is that of a high-level document that avoids the quagmire associated with the fine details of product development and testing. Whether this is the last word for some time on SaMD is difficult to forecast, but the reader will note that the agency took the unusual step of announcing the final guidance in the Federal Register, complete with the associated docket number.
The Risk of Saying Nothing About Risk
Conversely, the draft guidance for clinical decision support (CDS) systems presents the reader with a decidedly different dilemma, although it offers some useful content. The draft includes a section spelling out instances in which a CDS would not fall under FDA regulations, such as software that provides recommendations as to the use of a drug within the labeled indication. This document also provides a number of examples of uses of a CDS that would qualify the item as a device, but Bradley Merrill Thompson of Epstein Becker Green had a few choice words regarding the draft.
Thompson, who serves as the general counsel for the CDS Coalition, said the CDS draft lacks clarity on the point of how a vendor might determine how the risks associated with that product’s use might push the CDS into the agency’s regulatory territory. Thompson said this is particularly problematic given the recent and coming advances in artificial intelligence, although others indicated some relief that patient use of CDS was written into the document.
One way of looking at the risk question in this guidance – or more properly, the failure of the draft to directly address the risk question – is that the agency believes it might be a more economical use of its time to draw feedback from stakeholders before committing anything to ink. The docket is open for only sixty days, however, and it seems fairly plausible that the Feb. 6, 2018 deadline for comment will be extended if indeed the FDA intends to provide at least some discussion of risk. After all, the agency’s device center has expended a considerable amount of effort to talk about benefits and risks, including the final guidance on how the FDA will handle the hazards of dealing with problematic devices that may or may not warrant withdrawal.
The last of the three guidances released by the FDA on Dec. 7 was the draft guidance dealing with policy changes to four existing guidances, including the guidance for medical device data systems (MDDS). The agency’s proposal to regulate such software in 2011 sparked a lot of pushback from stakeholders with a lot of bandwidth on Capitol Hill, and the agency walked back from several major features of its early proposals several years ago. This guidance will be substantially revamped, although in its current form it is apparently not operational, as the saying goes.
The general wellness app guidance is also scheduled for a thorough rewrite, as are the guidances for mobile medical applications and off-the-shelf software used in medical devices. Device makers have the 21st Century Cures Act to thank for much of this, but the agency’s latest commissioner, Scott Gottlieb, might have pushed for many of these changes even without the help of the Cures Act. All in all, Dec. 7 was not a bad start to the holiday season, even if one or two items will eventually be re-gifted to the giver.