As part of an effort to streamline the regulatory process for digital health technologies that have potential to reduce cost and improve patient outcomes FDA is piloting a pre-cert program for digital health technologies.
FDA Commissioner Scott Gottlieb has announced further development in the regulatory framework of that program to test innovative approaches in providing regulatory review for software-based digital health products.
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The nine companies currently taking part in the FDA’s pre-cert program are Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily.
Essentially, the FDA is looking to create a regulatory pathway that judges software developers against certain so-called “Excellence Appraisal” guidelines which would allow for more a personalized submission process for their specific products.
The Excellence Appraisal portion of the pre-cert program would streamline much of the Quality System Regulation requirements necessary for the approval under the traditional De Novo regulatory pathway, which is the existing process the FDA has highlighted which would work best for most novel digital health solutions.
“By collecting this information early, the Excellence Appraisal could be leveraged to streamline a developer’s De Novo submission, reducing content the developer would need to submit to the agency under the De Novo pathway since the information would already have been demonstrated and documented during the Excellence Appraisal,” Gottlieb wrote in his announcement.
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“This allows the FDA to tailor the premarket submission content to the unique considerations related to each particular digital health device and enables more efficient evaluation of low-risk digital health devices.”
Over the next year the FDA intends to use its pilot program to set up two parallel review process, one through the Pre-Cert pathway and another through the traditional De Novo submission pathway to better gauge the benefits and efficiency gains of the alternative regulatory path.
The streamlined Pre-Cert De Novo submission is intended to include a plan from the manufacturer to monitor and evaluate the real-world performance of the software.
“Proactive monitoring of real-world performance enhances an understanding of how the software continues to perform while in use, while helping the developer and the FDA to quickly identify and address potential safety issues along with additional benefits to patients,” Gottlieb wrote in the announcement.
Picture: Getty Images, Mykyta Dolmatov
