Today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb announced that the Agency is issuing three new, significant policy documents to advance FDA’s approach to the development and oversight of innovative digital health tools. The first two documents are draft guidances, “Clinical and Patient Decision Support Software” (CDS Draft Guidance) and “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act” (Medical Software Policies Draft Guidance), and the third is a final guidance, “Software as a Medical Device: Clinical Evaluation” (SaMD Guidance).
Gottlieb’s announcement today comes on the heels of the Agency’s issuance of its Digital Health Innovation Plan (the Plan) this past summer. As we discussed here, FDA hopes that the Plan will encourage industry growth by providing more regulatory certainty to device developers. In the Plan, FDA committed to a number of goals, including increasing the number and expertise of digital health staff at the Agency, launching the digital health software precertification pilot program (Pre-Cert), and issuing guidance to modernize FDA’s digital health policies.
CDS Draft Guidance
In its CDS Draft Guidance, FDA attempts to clarify what types of CDS would no longer be defined as a medical device, and thus would not be regulated by the Agency. One such example is CDS that allows for the provider to independently review the basis for recommendations (e.g., software that suggests a provider order liver function tests before starting statin medication, consistent with clinical guidelines and approved drug labeling).
To be clear, the Agency will continue to maintain oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices, or patterns acquired from a processor (e.g., an electrocardiogram that use analytical functionalities to make treatment recommendations), as these remain medical devices.
Through the CDS Draft Guidance, FDA proposes to not enforce regulatory requirements for lower-risk decision support software that is intended to be used by patients or caregivers (i.e., patient decision support software (PDS)), when such software allows a patient or a caregiver to independently review the basis of the treatment recommendation (e.g., PDS that reminds a patient how or when to take a prescribed drug, consistent with the drug’s labeling). However, PDS that does not clearly allow independent review of the recommendation by the patient or a caregiver (e.g., a warfarin monitoring device that makes recommendations for dosing based on the outcome of a home blood test) would continue to be subject to the FDA’s medical device oversight.
Medical Software Policies Draft Guidance
In its Medical Software Policies Draft Guidance, the Agency sets forth its interpretation of the types of software that are no longer considered medical devices. FDA makes it clear that certain digital health technologies (e.g., mobile apps that are intended only for maintaining or encouraging a healthy lifestyle) generally fall outside the scope of FDA’s regulation. Per Gottlieb, such technologies tend to pose a low risk to patients but can provide great value to consumers and the healthcare system.
Given the nexus between the Medical Software Policies Draft Guidance and FDA’s “General Wellness” and “Mobile Medical Applications” (MMA) guidance documents, and in light of the Agency’s new, more modern approach to digital health products, FDA is using the Medical Software Policies Draft Guidance to propose changes to the General Wellness and MMA guidances. Such changes include updating the categories of products for which, prior to the 21st Century Cures Act (Cures Act), FDA already intended to exercise enforcement discretion because of their very low risk and potential benefits to patients. Now, consistent with the Cures Act, FDA is indicating that many of these products no longer qualify as medical devices that would be subject to the Agency’s oversight.
Finally, in its SaMD Guidance, FDA expands on the October 2016 draft version of the same and establishes common principles for regulators to use in evaluating the safety, effectiveness, and performance of SaMD. The Guidance provides globally-recognized principles for analyzing and assessing SaMD, based on the overall risk of the product. Per Gottlieb, the Agency’s adoption of these principles provides FDA with an initial framework for developing SaMD regulatory approaches and expectations for regulatory oversight.