The FDA continues to address items on its Digital Health Innovation Action Plan. After recently issuing proposed guidance and a pilot program relevant to Software as a Medical Device (“SaMD”), the FDA issued a final guidance regarding SaMD on December 8, 2017. The guidance adopts a set of quality management principles relevant to “software that utilizes an algorithm (logic, set of rules, or model) that operates on data input (digitized content) to produce an output” such as informing, diagnosing, or treating a patient.
In a press release announcing the final guidance, FDA Commissioner Scott Gottlieb stated:
This final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product. . . . [W]e’re issuing new details on the common principles we and our international partners will use for evaluating the safety and effectiveness of SaMD.
The principles referred to by Commissioner Gottlieb include the following SaMD Quality Management Principles:
- An organizational structure that provides leadership, accountability, and governance with adequate resources to assure the safety, effectiveness, and performance of SaMD;
- A set of SaMD lifecycle support processes that are scalable for the size of the organization and are applied consistently across all realization and use processes; and
- A set of realization and use processes that are scalable for the type of SaMD and the size of the organization; and that takes into account important elements required for assuring the safety, effectiveness, and performance of SaMD.
Commissioner Gottlieb further opined that this guidance and the IMDRF principles within it “provide [the FDA] with an initial framework when further developing [the FDA’s] own specific regulatory approaches and expectations for regulatory oversight.”