“FDA Guidance on Decision Support Software: Implications for Industry” Featured in POLITICO Morning eHealthPOLITICO Morning eHealth January 4, 2018
POLITICO Morning eHealth recently featured “FDA Guidance on Decision Support Software: Implications for Industry,” co-authored by Bradley Merrill Thompson, a Member of the Firm, and Daniel Kim, a Law Clerk – Admission Pending, in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, in their “What We’re Clicking On” section.
Following is an excerpt:
Epstein Becker Green’s Bradley Merrill Thompson and Daniel Kim offer their takes on the FDA clinical decision support guidance. …
On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Clinical and Patient Decision Support Software” (“CDS Guidance”). According to FDA Commissioner Scott Gottlieb, M.D., the CDS Guidance is intended to clarify the types of clinical decision support software (“CDS”) that would no longer be defined as a medical device and, therefore, would not be regulated by the FDA.
Stakeholders in the digital health industry have long awaited clarification of the scope of the FDA’s regulatory oversight of CDS, specifically the differentiation between low-risk and high-risk CDS. The FDA had first announced its plan to develop guidance for CDS in 2011. Unfortunately, stakeholders seeking clarity may have to wait longer.