Megan Robertson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in BioWorld, in “FDA Reissues Controversial CDS Final Guidance,” by Mark McCarty. (Read the full version – subscription required.)
Following is an excerpt:
Megan Robertson of Epstein Becker & Green P.C., told BioWorld that Makary’s announcement regarding the two new guidances suggests that CDRH will receive more scrutiny from the commissioner’s office going forward. Robertson said the agency’s previously demonstrated interest in wearables also suggests more interesting in the goings-on at CDRH on the part of the commissioner.
Despite the rhetoric from Makary and Kennedy, there were few indicators of a greater focus on CDRH at the end of 2025, Robertson observed. However, Makary’s Jan. 6 announcement lends credence to the notion that CDRH will receive more attention from the commissioner’s office despite the louder conversations about vaccines and drug development from the agency’s two other life science product centers, she said.
Robertson said the FDA’s Digital Health Center of Excellence, too, might receive more attention from Makary this coming year, but there is still an open question as to how persistent that scrutiny will ultimately hold. Precisely what led to the focus on the CDS final guidance is difficult to characterize, although Robertson made note of the fact that CDRH has not undergone any changes to the leadership team while the centers for drugs and biologics have seen at least some reshuffling of the leadership deck.
The FDA’s December 2025 announcement regarding the so-called TEMPO pilot program might also serve as a signal of FDA’s sharpening interest in digital health, Robertson said. TEMPO is the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, which the agency described as a voluntary pilot “designed to promote access to certain digital health devices” using a risk-based approach to oversight. This program will be directed to products dealing with cardio-kidney-metabolic diseases, musculoskeletal health, and behavioral health conditions. Robertson said the institution of this pilot might have prompted the commissioner’s office to investigate digital matters such as the CDS controversy.
More nuance on how physicians use CDS products
Robertson said one of the more noticeable elements of the new guidance is the discussion of a CDS that provides only one recommendation for diagnosis or patient treatment under the third criterion. The updated guidance says that the agency will exercise enforcement discretion in this scenario assuming the CDS meets the other three categories of requirements. This provision “seems to show they understand that a CDS tool doesn’t automatically compromise the provider’s clinical judgment,” Robertson observed. This change suggests a more nuanced understanding on the agency’s part regarding the interplay between the practice of medicine and a device’s software function, she added.
Still, Robertson said this is unlikely the last time the FDA will look at the CDS policy. “Personally, I think it’s going to need more work” as developers continue to integrate their digital products into the health care systems. This process is likely to present new dilemmas that will force a few tweaks of the guidance. However, she also remarked that the agency’s failure to provide a draft version of this latest guidance is also a point of interest. While industry is unlikely to challenge the guidance, the FDA’s own good guidance practices manual would seem to shine an unsparing light on the failure to float a draft version of this guidance.
Sub-regulatory guidance is not formally subject to the terms of the Administrative Procedures Act (APA), Robertson said. All the same, any would-be litigants could make the argument that a guidance as important and controversial as the CDS guidance should be subject to the spirit of the APA, even if the act does not legally mandate notice-and-comment processes for sub-regulatory guidance development, she remarked.
