The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated.
One of the draft guidances, the 13-page “Clinical and Patient Decision Support Software,” outlines which types of clinical decision support software (CDS), which can compare patient-specific signs with available clinical guidelines to recommend treatments, would no longer be defined as a medical device, and thus would not be regulated.
“For example, generally, CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation,” FDA Commissioner Scott Gottlieb, who testified before the Senate Committee on Health, Education, Labor & Pensions on Wednesday, said in a statement.
The draft also proposes to not enforce regulatory requirements for lower-risk decision support software intended to be used by patients or caregivers, including software that reminds a patient how or when to take a prescribed drug.
But FDA will continue to enforce oversight of software intended to process or analyze medical images, signals from in vitro diagnostics or from a processor like an electrocardiogram, Gottlieb said, noting that software that uses analytical functionalities to make treatment recommendations remains a medical device under the 21st Century Cures Act.
“For example, we would continue to oversee software that analyzes data from a patient’s spinal fluid test to diagnose tuberculosis meningitis or viral meningitis. These are areas in which the information provided in the clinical decision software, if not accurate, has the potential for significant patient harm, and the FDA plays an important role in ensuring the safety and effectiveness of these products,” Gottlieb added.
And mobile apps – like FitBits or certain step trackers that are intended only for maintaining or encouraging a healthy lifestyle – generally fall outside the scope of FDA’s regulation, FDA said in another draft guidance released Wednesday, the 14-page “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21stCentury Cures Act.”
Through this draft, FDA is proposing changes to previously published guidance on General Wellness and Mobile Medical Applications, among others, to be consistent with Cures.
FDA on Wednesday also issued a final guidance developed with the International Medical Device Regulators Forum (IMDRF), known as “Software as a Medical Device: Clinical Evaluation.” Drafted in October 2016, the final guidance expands on that draft and establishes common principles for regulators to use in evaluating the safety, effectiveness and performance of Software as a Medical Device (SaMD). This final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product.
In addition to the new guidance, on 30-31 January 2018, FDA will host a free public workshop Fostering Digital Health Innovation: Developing the Software Precertification Program at the National Institutes of Health Campus in Bethesda, MD.