The FDA has recognized that the current regulatory pathways for Software as a Medical Device (SaMD) do not let them assess the safety and effectiveness of new SaMD products at the pace of modern software development. This fact likely limits the availability of new software applications that could significantly benefit patients. The agency is developing the Software Pre-Certification Pilot program (the Pre-Cert program) to provide a more streamlined and efficient regulatory pathway for SaMD.

In early January 2019, the agency issued 3 new documents to advance the Pre-Cert program towards full regulatory implementation. These new documents include:

1. Pre-Cert Working Model Version 1.0 – this document presents the current version of the program’s model and is an update from version 0.2 issued in June 2018.
2. Pre-Cert 2019 Test Plan – this document presents CDRH’s plan to test and update the working model in 2019.
3. Pre-Cert Regulatory Framework for Conducting the Pilot Program – this document shows how CDRH will implement the pilot program under current statutes and regulations.

Together these three documents establish how CDRH intends to advance the pilot program in 2019. This is the first of two posts discussing the agency’s planned activities.

The development of the pilot program is expected to be iterative – as the agency develops data this year, they intent to publish program updates, including updates to the working model document. What’s interesting and novel about the Pre-Cert program is the agency’s intent to use basic quality principles to first establish a software company’s commitment to excellence and use that information to establish a Pre-Certification level for that company. This Pre-Cert level will be used along with risk category for the proposed SaMD to determine the level of premarket review needed for the new software. A significant portion of the data normally submitted in a premarket application will be evaluated during the Pre-Cert process, which will streamline the requirements for the premarket review. Practitioners of quality will recognize the 5 culture of quality and organizational excellence (CQOE) principles which will be used to evaluate a company’s commitment to excellence in the Pre-Cert process:  product quality, patient safety, clinical excellence, cybersecurity responsibility, and proactive culture. Other quality elements in the program include use of the Total Product Lifecycle concept to guide excellence appraisal, review determination, streamlined review (where necessary), and post marketing evaluation of real-world performance. This approach is consistent with global quality approaches already in place in many domains including software development, and therefore should be more easily adapted by companies previously unused to working with the FDA.

In the next post I’ll discuss the test plan and regulatory framework for the Pre-Cert Pilot program. You may read more about the program at its website, and submit comments at the program’s docket.

Text Copyright © 2019 Katrina Rogers