The draft guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act offers further clarity for manufacturers on the impact of the 21st Century Cures Act on FDA’s pre-existing digital health policy and addresses proposed changes to previously-published FDA guidances, including: General Wellness: Policy for Low Risk Devices; Mobile Medical Applications; Off-The-Shelf Software Use in Medical Devices; and Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices to help manufacturers understand what products meet the definition of “device” under the new law.
The second draft guidance issued today, Clinical and Patient Decision Support Software clarifies the types of clinical decision support software that would be regulated by the Agency, post-21st Century Cures Act. The draft guidance also proposes to not enforce regulatory requirements for lower-risk decision software that is intended to be used by patients or caregivers, known as patient decision support software -- when such software allows a patient or a caregiver to independently review the basis of the treatment recommendation. Clinical decision support software can include programs that compare patient-specific signs, symptoms or results with available clinical guidelines to recommend diagnostic tests, investigations or therapy, while patient decision support software could include software that reminds a patient how or when to take a prescribed drug, consistent with the drug’s labeling. We believe our proposals for regulating digital health products not only fulfill the provisions of the 21st Century Cures Act, but also strike the right balance between ensuring patient safety and promoting innovation.
The final guidance, Software as a Medical Device: Clinical Evaluation, initially issued as draft in October 2016, was informed by global and domestic comments and was prepared as part of FDA’s work with the International Medical Device Regulators Forum. The final guidance focuses on principles of clinical evaluation, which include establishing the scientific validity, clinical performance, and analytical validity for Software as a Medical Device. The agency’s adoption of these principles provides us with an initial framework when further developing our own specific regulatory approaches and expectations for regulatory oversight. The FDA expects to propose any specific applications of these harmonized principles to US requirements through a vehicle that provides the opportunity for public comments.
On January 30-31, 2018, the FDA will host the public workshop Fostering Digital Health Innovation: Developing the Software Precertification Program at the National Institutes of Health Campus in Bethesda, MD. This workshop will also be Webcast. The deadline to register for this free workshop is January 18, 2018, 4:00 p.m. Eastern Time.
We recognize that our regulations play a crucial role in the development of tools that can help people be more informed about their health. Therefore, our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation, while protecting public health; we will continue working towards that goal.
If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email firstname.lastname@example.org.
U.S. Food and Drug Administration