Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Healthcare Dive, in “Latest FDA Clinical Decision Support Software Draft a Step Forward, Industry Says,” by David Lim.
Following is an excerpt:
The latest draft guidance uses the International Medical Device Regulators Forum’s risk-based framework to determine which types of software falls under regulatory oversight, with FDA intending to scrutinize software that informs clinical management of serious conditions where a health provider cannot independently review the basis of its recommendations. …
The CDS Coalition, which represents software providers among other stakeholders, wrote FDA’s new draft guidance, while a step forward towards a risk based approach, does not implement the IMDRF framework consistently. It argues FDA did not exempt Software as a Medical Device that drives clinical management of a disease in a non-serious situation or condition, or software that informs clinical management for disease in a serious situation or condition, both of which are listed in IMDRF’s framework as subcategories of informing clinical management category.
“The effect is to only exempt one out of the 22 products listed in that appendix A. That is a very small step indeed. And the agency offers absolutely no justification or explanation as to why the first two subcategories — categories that contain the other 21 products — should not also be exempt,” CDS Coalition General Counsel Brad Thompson wrote.
