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FDA’s Software Precertification Program

Author: Carrie Hetrick | Date: August 26, 2021

In today’s digital era, Software as a Medical Device (SaMD) is revolutionizing the healthcare field. From informing and driving medical decisions to diagnosing and treating patients, SaMDs offer a modern approach to patient care.

The FDA plays a critical role in ensuring these technologies are safe and effective when used for medical purposes. Given the proliferation of SaMDs and the rapid pace at which they are being developed and brought to market, the FDA decided to update its approach to digital health regulation. Enter: the FDA’s software precertification program.

The FDA’s goal for its software precertification program is to “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.”

Designed to give patients quicker access to SaMDs and support innovation while upholding the standards of device safety and effectiveness, the FDA’s pre-cert program embodies three core shifts:

  • Transitioning from that of a pre-market evaluation of just the product to one that includes a review of both the product and the company
  • Moving away from periodic reviews to a continuous review process that monitors devices on the market
  • Doing away with timely manual reviews in favor of reviews that incorporate new tools that drive efficiencies


To ensure the standards for protecting and promoting safety are upheld, the agency created five excellence principles that serve as the basis for the FDA’s software precertification program. Only those that meet the below criteria will be pre-certified:

  1.  Provide a safe patient experience
  2.  Develop, test and maintain high-quality products
  3.  Conduct responsible, patient-centric clinical evaluations
  4.  Ensure cybersecurity
  5.  Maintain a proactive approach to identifying and addressing issues

 Here’s how the FDA software precertification program works:

A company will first go through an appraisal process, whereby the FDA evaluates how the company’s culture and process impact the development of the software. This information helps the FDA determine whether they can trust the company to develop and maintain SaMDs in a safe and effective manner. Companies that meet the requirements (i.e., they demonstrated a culture of quality and organizational excellence) will be pre-certified.

Once the FDA pre-certifies a company, they then evaluate the software for functionality and intended use, while the company uses the FDA’s risk-based framework to determine the software’s risk categorization. The information from the evaluation and risk assessment is then used to determine which review pathway the SaMD will follow: Higher risk SaMDs go through a streamlined review process that includes an additional product-level evaluation by the FDA, while lower risk SaMDs follow a pathway where the FDA and the company work together to monitor the product’s real-world performance. Once in the hands of the consumers, the product is continually monitored using real-world performance data to inform and maintain continued pre-certification status moving forward.

The FDA’s pre-cert program is currently in pilot phase as the FDA explores the feasibility of the reimagined approach. Over the next few years, the FDA expects to move into beta for more extensive testing, followed by a full launch. Stay tuned for updates as we learn more about the FDA’s evolving software precertification program.

For more information about the FDA’s software precertification program and what it means to you, or to discuss your medical device system development needs, contact us here.

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