The 21st Century Cures Act, enacted in December 2016, amended the definition of “medical device” in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) to exclude five distinct categories of software or digital health products. In response, the US Food and Drug Administration (FDA) issued new digital health guidance and revised several pre-existing medical device guidance documents. FDA also stated that it would continue to assess how to update and revise these guidance documents as its thinking evolved.
Late last week, FDA issued five final guidance documents and re-issued a draft guidance document to better reflect FDA’s current thinking on software as a medical device (SaMD) and other digital health products:
- Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act – Guidance for Industry and Food and Drug Administration Staff
- General Wellness: Policy for Low Risk Devices – Guidance for Industry and Food and Drug Administration Staff
- Policy for Device Software Functions and Mobile Medical Applications – Guidance for Industry and Food and Drug Administration Staff
- Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices – Guidance for Industry and Food and Drug Administration Staff
- Off-The-Shelf Software Use in Medical Devices – Guidance for Industry and Food and Drug Administration Staff
- Clinical Decision Support Software – Draft Guidance for Industry and Food and Drug Administration Staff
Most of the guidance documents reflect modest changes to prior draft guidance documents that describe categories of low-risk health and wellness devices that FDA does not intend to regulate. FDA’s new draft Clinical Decision Support (CDS) Software guidance, however, provides a new and more detailed analysis of risk factors that FDA will apply to determine whether a CDS tool is a medical device. FDA updated its previously issued draft CDS guidance without finalizing it. Although the new guidance does not explain why FDA is reissuing the CDS guidance in draft, the new draft guidance seems to reflect the agency’s attempt to better align its definition of non-device software with the often misunderstood and misinterpreted statutory definition of CDS in section 520(o)(1)(E) of the Cures Act. The chart below summarizes the key provisions and changes to these guidance documents.
Digital health products can present a particular challenge for developers and regulators in assessing the appropriate regulatory pathways for a new product. The updated guidance documents reflect the need for a more flexible, risk-based approach to regulation that accommodates a rapidly evolving technological landscape. These documents also reflect what appears to be the new normal for digital health regulation—the need for iterative thinking and ongoing revisions to interpretive guidance documents to keep pace with a constantly changing marketplace.