Some Decision Support Language Unclear: Comment

GE Healthcare says it recognizes and appreciates FDA efforts to bring clarity and the appropriate level of regulatory oversight to clinical and patient decision support software, but is concerned that some language in a draft guidance “raises some questions and uncertainty regarding scope and extent of the proposed level of oversight.” The company’s letter says the language may result in an unintended consequence of limiting innovation that may not fully correspond to the needs of protecting public health. The company says the draft guidance does not appear to take into account the risk associated with clinical decision support functionality as part of the basis for regulation and establishing enforcement priorities.

In its comment, AstraZeneca asks for clarification on the applicability of the draft to drug, biologics, and combination product sponsors.