- FDA's second attempt at a regulatory approach to clinical decision support software appears to be better received by the medical device industry, which lauded the agency for taking a risk-based approach after its first attempt in 2017 drew a multitude of complaints. But America's largest association of physicians is raising concern the approach may exclude too many types of software from regulation, potentially putting patients at risk.
- Still, the Clinical Decision Support Coalition pressed FDA to exclude more software as low risk and not limit enforcement discretion to patient-directed software for non-serious situations or conditions. AdvaMed said FDA's new draft guidance is consistent with congressional intent, but asked the agency to provide flowcharts or other methods to help manufacturers and developers determine the regulatory status of their products.
- The American Hospital Association wrote that while it supports FDA oversight of software that "automatically determines clinical treatment or action," the agency must clarify when downstream software, such as an algorithm that analyzes data from an EHR, is subject to FDA oversight. The group argued such software that helps provide insights to healthcare providers by examining "downstream" data should be exempt from FDA regulation.
The latest draft guidance uses the International Medical Device Regulators Forum's risk-based framework to determine which types of software falls under regulatory oversight, with FDA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 American Medical Association wrote reliance on software exempted under the IMDRF's risk framework approach to non-serious conditions could "lead to the proliferation of CDS tools for 'non-serious conditions' that are faulty, inaccurate, and without validation, potentially leading to patient harm."
"We strongly urge the FDA to revisit this component of the Draft 2019 Guidance. At a minimum, we urge FDA to work with FTC to issue consumer protection guidance, ensuring that developers understand that they are required to ensure the safety, efficacy, and equity of such tools as the baseline for adhering to consumer protection laws," AMA CEO James Madara wrote.
The American Hospital Association wrote that the draft guidance creates two categories under the IMDRF framework: software that "informs clinical management" and software that "drives clinical management," the latter of which may be subject to FDA regulation. The group said FDA interpretation of the language could "apply an arbitrary distinction ... that is not directly supported by the statute."
"We are concerned that the FDA's interpretation of certain criteria could result in many existing CDS algorithms being subject to the FDA approval process and ultimately slow the pace of innovation and development of new software tools to support better patient care and outcomes," wrote Ashley Thompson, AHA SVP of public policy analysis and development.
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.