The Software FDA Pre-Cert Program is a pathway that comprises a regulatory model which is more visible than the current model to assess the safety and effectiveness, without inhibiting patient access, of software technologies which are being used as Medical Devices.

The U.S. Food and Drug Administration (FDA) introduced Software Precertification program to address problems that the SaMD manufacturers are facing and provide suitable regulatory surveillance of software-based medical devices.

The Primary Goal of this program is to facilitate the development of software technologies and expedite patient access to these technologies.

Current Challenges

Lack of Transparency

Expectations between FDA and Manufacturers are not fully transparent. The Manufacturers of SaMD do not have a complete understanding of what is expected from them in terms of testing or data that they need to provide to the regulatory bodies in order to receive regulatory approvals or clearances.

Nature of SaMD

Unlike the hardware manufacturers who modify their products for a few months to years, SaMD manufacturers modify their products more often (a few weeks to months) in response to real-world performance and user feedback. 

This problem is unique to SaMD because the software just by virtue of its nature needs to be updated every now and then for defect corrections and to make it a better fit for its users. 

The FDA was discussing the FDA Pre-Cert program since 2017 and finally launched the Pre-Cert program at a pilot level in the year 2019. For the pilot program, manufacturers having a sturdy Culture of Quality and Organizational Excellence (CQOE) principles (hereafter referred to as “excellence principles”) were selected. The Excellence Principles are as follows:

● Product Quality
● Patient Safety
● Clinical Responsibility
● Cybersecurity Responsibility
● Proactive Culture

The FDA applies the Total Product Lifecycle (TPLC) approach to empower the assessment and monitoring of the Software Product from its premarket development to post-market performance along with the continued exhibition of organization’s excellence. The goals of the Precertification Pilot Program are:

● Assessment of the organizations for ensuring that they develop high-quality software products

● Utilization of a streamlined premarket review that leverages unique postmarket opportunities to verify the safety, effectiveness and performance of the software product in the real world

Further, the program has been divided into four key components to outline the goals of the Precertification program.

Key Component of Precertification Program (Procedure for the program) (1)

Maintenance and Monitoring of FDA Pre-Cert Program Status 

The Manufacturers, who are a part of the pre-cert program, shall trace and monitor their compliance with the excellence principles to ensure the safe and effective operation of their commercially distributed software (at various risk levels shown in the figure below) by responding appropriately to the post-market indicators.

Table 1: Category of SaMD based on Risk Levels


The Software Precertification program benefits the organization’s ability to participate in a streamlined pre-market review and opportunities to collect and leverage real-world post-market data and ensure optimal quality of software products throughout their life cycle. 

To make the best use of the FDA Pre-Cert program manufacturer’s must work with strong Regulatory Partners. For comments or questions please reach out to  We at Elexes have a team of experts who can help you through the entire life cycle of medical device regulatory affairs. All you have to do is contact us

NOTE: The FDA may modify the Pre-Cert Program based on the feedback collected from the Pre-cert Pilot Program.

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