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Software Precertification

The Software Precertification (Pre-Cert) Pilot Program 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.


Proposed Key Components:

Excellence Appraisal and Determining Precertification Level: Identifying the objective criteria and methodology that the FDA will use to pre-certify a company and decide whether a company can keep its precertification status.


Review Pathway Determination: Developing a risk-based framework so that a precertified company can determine the premarket review pathway for their products. Potentially precertified companies could market their lower-risk devices without FDA premarket review or only a streamlined premarket review based on the company's precertification level and International Medical Device Regulators Forum (IMDRF) risk categorization.

The FDA is planning to leverage the IMDRF framework in determining the risk categorization of a SaMD product, incorporating information about the medical purpose of the SaMD and the seriousness of the medical condition that the SaMD is intended to treat.




Monitoring Real-world Performance: Identifying the type of information that a precertified company may have access to about how its software product is performing with patients to support the regulatory status of the product and new and evolving product functions.


What is the Goal of the Pre-Cert Pilot Program?



  • Benefit a participating organization based on its "precertified" status by offering the ability to market lower risk software as a medical device (SaMD) without premarket review of individual products, or participate in a streamlined premarket review and opportunities to collect and leverage real-world postmarket data.