The FDA recently announced its Digital Health Innovation Action Plan. This plan was both important and necessary. Digital health differs significantly from drugs and traditional medical devices around which the FDA has developed its structure and policies over decades. Digital health software technologies have far less involvement by clinicians in product development than Pharma or medical device companies. Innovation and improvements in digital health occur at lightning speed in comparison to other FDA regulated industries and require different approval and oversight strategies (see below). Multifunctional digital health technology interacting with both drugs and devices creates a need for a new agency framework and workflow for such combined products. The Action Plan is a major step in the right direction because it recognizes digital health’s unique attributes which span both IT and clinical arenas. In addition it recognizes the need for infrastructural and process changes in the agency itself. It will address lingering issues such as multifunctional software (technology which has software qualifying as a medical device combined with that which doesn’t).
- The Action Plan builds on and improves previous digital health guidances. The FDA has previously released guidance documents on Mobile Medical Apps and General Principles of Software Validation. These were a well thought out and developed group of guidelines with patient safety as a focus. The Action plan includes a plan to issue a new draft guidance by the end of 2017 on mobile medical apps, medical device data systems (used for the electronic transfer, storage, display, or conversion of medical device data), medical image storage devices, medical image communications devices, low-risk general wellness products, and laboratory workflow. This guidance will reflect the impact of The 21st Century Cures Act passed by Congress last year on previous FDA guidelines on software. The FDASIA Health IT Report from the Office of the National Coordinator left many unanswered questions about clinical decision support technologies. The Action Plan is in part designed to address that gap by planning a Guidance on Clinical Decision Support by Q1 of 2018.
- The FDA will have new digital health experts. The Innovation plan reflects the need for hiring digital health technology experts by the agency. According to the Action Plan, the FDA’s goal is “is to build a cadre of experts with a deep understanding and experience with software development and its application to medical devices. This new staff will work with reviewers, compliance officers, and others within the FDA to improve the quality, predictability, consistency, timeliness, and efficiency of decision-making on individual products and firms.” In addition, the agency is to launch an Entrepreneurs in Residence program for “…thought leaders and others with real experience in software development to build and structure the digital health function within CDRH [FDA’s Center for Devices and Radiologic Health] as it – and the market – grows.” This input from industry leaders will provide the leadership in designing the FDA’s structure and approach in order for it to get digital health addressed in the manner it deserves.
- A Pre-cert program will be about the developer not the software. A simplistic explanation of this program would describe it as analogous to the TSA’s Precheck Program. According to the Action Plan, this Software Certification Pilot Program “… could “pre-certify” eligible digital health developers who demonstrate a culture of quality and organizational excellence based on objective criteria, for example, that they can and do excel in software design, development, and validation (testing). Pre-certified developers could then qualify to be able to market their lower-risk devices without additional FDA review or with a more streamlined premarket review.” This program would both set quality development standards and streamline approval processes. This pre-cert pilot program is admirably designed “…to leverage customer input to develop a program that can help reduce the time and cost of market entry for software developers that FDA determines reliably manufacture high-quality, safe and effective digital health devices while providing appropriate patient safeguards.”
- The FDA will work with other global agencies. Last year the International Medical Device Regulators Forum (IMDRF) published a proposal for the clinical evaluation of software as a medical device. The FDA issued this as a draft guidance and it is expected to adopt the final IMDRF version as a final guidance. This global initiative will allow for faster, less expensive and standardized adoption and oversight of this type of technology.
- The upgrade approval process will be clarified. The Action Plan calls for a final version guidance by the end of 2017 of its draft proposal of Deciding When to Submit a 510(k) Software Change to an Existing Device. The Plan states that this final guidance “includes guiding principles as well as a simple to follow flow chart, with the aim of setting clear, practical, and transparent regulatory expectations.”
This Action Plan seeks to improve on previous FDA guidances and initiatives. It recognizes the need for infrastructural changes of the FDA itself to support digital health, and necessary input from industry leaders. Bakul Patel and the FDA should be commended for developing this Action Plan in response to industry leaders looking for detailed support for improving, crystallizing, standardizing, and streamlining oversight policies. I look forward to downstream developments arising from it and encourage those developers clamoring for a voice at the table to apply for the Pre-Cert Pilot Program.