Nine companies have been selected to participate in the FDA’s digital health software precertification pilot (FDA Pre-cert), to help advance digital health regulation in the US.
During his keynote address at the AdvaMed MedTech Conference, FDA commissioner Scott Gottlieb announced which companies would be taking part in the pilot. He said: “Our method for regulating digital health products must recognise the unique and iterative characteristics of these products. We need to modernise our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product.”
The nine companies selected or the Pre-cert pilot include, Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily.
The FDA hopes that the Pre-cert pilot programme will help it put the right policies in place to promote safe and effective digital health products. The pilot will involve the FDA examining the software/digital health developer rather than the product itself to determine whether the company meets quality standards. The FDA will review systems for software design, validation and maintenance and if the company meets the standards, it will be precertified.
The FDA hopes that the information gained through the pilot will help determine the key metrics and performance indicators for precertification. The pilot is also intended as a way for the FDA to see if companies can submit less information than currently required before marketing a new digital health product. The organisation is also examining whether precertififed companies may not have to submit a product for premarket review.
Over 100 companies applied to take part in the pilot. The FDA had to consider several factors when selecting the participants such as company size, demonstrated record of quality, organisation excellence, clinical focus area and the risk profile of the product. The FDA states that it selected companies that represent different perspectives and unique approaches to digital health technology development.
Participants of the pilot have agreed to provide access to the measures they are using to develop, test and maintain their products, as well as how they collect post-market data. The companies will also be available for site visits by the FDA to provide information about their quality management system.
Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, said: “We are extremely appreciative of the tremendous interest in participating in the FDA Pre-cert pilot program. The number of applicants speaks to the significant impact this approach could have on facilitating timely advancement of software that has the potential to benefit health. The diversity of the Pre-cert pilot program participants means that we will receive a variety of input on how the industry defines organisational excellence and other key performance indicators. This feedback will be invaluable as we progress through the pilot and onto the next stages of digital health oversight.”
James Park, co-founder and CEO of Fitbit, said: “We applaud the FDA for taking a progressive and thoughtful approach to designing a potential new digital health regulatory framework and are proud to have been selected to participate in this innovative pilot program. As Fitbit takes a more integrated role in personal healthcare, we are hopeful this will allow us to accelerate FDA regulated features and software development, bringing new capabilities that could positively impact health outcomes to market more quickly.”