About FDA

The FDA's Digital Health Software Pre-Certification (Pre-Cert) Program will enable the FDA to develop a tailored approach toward regulating digital health and software technologies

The challenge

How might we help the Food and Drug Administration inform the development of a regulatory model to assess the safety and effectiveness of software technologies without inhibiting patient access to these technologies?

Digital health tools have vast potential improve our ability to accurately diagnose and treat disease. And to enhance the delivery of health care for the individual, making medical care truly patient centric – empowering the individual.

The FDA is actively taking steps to ensure that public reaps the benefits from this change. The FDA is expanding its novel model for the pre-market review of digital health tools as medical devices, through our new software manufacture Pre-Certification (Pre-Cert) program, which implements a new approach to the review of software-as-a medical device (e.g., SaMDs including artificial intelligence and machine learning algorithms).

The Software Pre-Certification (Pre-Cert) Pilot Program, as outlined in the FDA’s Digital Health Innovation Action Plan[https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/UCM568735.pdf] will help inform the development of a regulatory model to assess the safety and effectiveness of software technologies without inhibiting patient access to these technologies.

The FDA envisions that the future regulatory model will provide more streamlined and efficient regulatory oversight of software-based medical devices developed by manufacturers who have demonstrated a robust culture of quality and organizational excellence, and who are committed to monitoring real-world performance of their products once they reach the U.S. market. This proposed approach aims to look first at the software developer and/or digital health technology developer, rather than primarily at the product, which is what we currently do for traditional medical devices.

Because software products can be adapted to respond to glitches, adverse events, and other safety concerns quickly, the FDA is working to establish a regulatory framework that is equally responsive when issues arise to help ensure consumers continue to have access to safe and effective products. In the Pre-Cert program, the FDA is proposing that software products from pre-certified companies would continue to meet the same safety and effectiveness standard that the agency expects for products that have followed the traditional path to market.