On June 14, 2023 the U.S. Food and Drug Administration (FDA) finalized a new guidance document (Content of Premarket Submissions for Device Software Functions) that could be the shift in policy that marks a significant step towards modernizing and streamlining the regulatory process for medical device software, potentially leading to faster innovation and improved patient care. This blog post will discuss these new concepts and their potential impact on the industry.
The Food and Drug Omnibus Reform Act of 2022 (FDORA)
The FDORA of 2022 contained legislation to reform the regulatory framework. Specifically, Section 3308 of the FDORA of 2022 amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that the FDA establish a program to expedite the development and review of certain breakthrough devices.
The FDORA of 2022 introduced a new concept called the Predetermined Change Control Plan (PCCP). Under section 515C of the FDORA, the FDA can approve or clear a PCCP for a device that describes planned changes that may be made to the device and that would otherwise require a supplemental premarket approval application or premarket notification.
This means that manufacturers can now make certain changes to their devices without having to submit a new premarket approval application or premarket notification, as long as these changes are consistent with an FDA-approved or cleared PCCP. This could potentially streamline the process of making changes to medical devices, saving manufacturers time and resources.
Documentation Levels
The FDA also introduces the concept of Documentation Levels. There are two levels of documentation – Basic and Enhanced.
The Basic Documentation Level includes software description, risk management file, software requirements specification, system and software architecture diagram, and software design specification.
The Enhanced Documentation Level, in addition to the basic level, requires all unit and integration level test protocols and reports.
This new approach allows the FDA to tailor its documentation requirements based on the complexity and risk associated with a particular device.
IEC 62304 Alignment
IEC 62304 is a standard which provides a framework for a software development life cycle and tasks necessary to ensure safe and effective medical device software that meets its intended use and user needs. The guidance document provides a clear view on the IEC 62304 standard. It recognizes the importance of the standard in the development of medical device software and aligns its recommendations with the principles of IEC 62304.
Unresolved Software Anomalies
The guidance document also discusses the concept of unresolved software anomalies. An unresolved software anomaly is a defect that still resides in the software because a manufacturer deemed it appropriate not to correct or fix the anomaly, according to a risk-based rationale about its impact on the device’s safety and effectiveness.
Content of Premarket Submissions for Device Software Functions Guidance
The new FDA concepts introduced in the guidance document could significantly change the way manufacturers develop and validate medical device software. By allowing manufacturers to make certain changes to their devices without having to submit a new premarket approval application or premarket notification, and by tailoring documentation requirements based on the complexity and risk associated with a particular device, the FDA is streamlining the process. In addition, the clear alignment with IEC 62304 indicates that the FDA views the IEC 62304 standard as a valuable framework for the development and validation of medical device software.
How do you think these changes will impact the future of medical device software?
Share your thoughts in the comments below.
C. Austin Insight 