FDA’s Takes A Developer-Friendly Approach to Regulating Software

Last week FDA announced one of the biggest reshuffle in its policies for regulating software that should drastically reduce pre-approval regulatory burden on the developers and focus resources on evaluation of post-market consumer use data. FDA will change its traditional process for software as a medical device (SaMD) and use a revolutionary new approach to market approval based on perceived risk of software based on how it is developed and used. FDA’s Digital Health Innovation Action Plan acknowledges that the software that meets the current definition of a medical device should not be treated as other medical devices. Rather software should be regulated based on how it was developed and how it is used in the real world by consumers. The most disruptive element of the Action Plan is to pre-certify certain kind of developers so they can develop software products faster and with minimal oversight. Developers who demonstrate an embedded Culture of Quality and Organizational Excellence (CQOE) to FDA will be pre-certified to develop regulated software. Such pre-certified developers will need to submit minimal information in support of the market approval of the software they develop, and commit to providing post-market real world user data. The pre-certification process is being run on a pilot basis for one year with a maximum of 9 developers. The criteria for selection of software developers is based on key performance indicators such as the management resources available within the organization, customer support, product support, employee training, stakeholder engagement, product engineering, risk management commitment, efficiency, and revenue. FDA expects to attract a mix of developers with extensive experience in developing SaMDs, and some new and resourceful developers. The criteria are kept very broad to attract a variety of developers and provide greater flexibility to FDA’s selectors. The pre-certified developers will be frequently reassessed to evaluate the CQOE measures, will be required to submit post-market performance data on their SaMD, be available for real-time consultations with FDA, allow audits and site visits from FDA, and maintain quality management system. After the one year pilot program, FDA will review the experience and decide if the pre-certification program should be made permanent. In addition to the pre-certification program, FDA will release about 6 new guidance documents within a year. The Action Plan is being promoted as a consumer empowerment initiative that will advance digital healthcare, and it ultimately will; but in the near future, it is a gift to the developers who can rely on a friendlier FDA to ease the path to market.