FDA Releases Guidance For Clinical Evaluation Of Software As A Medical Device
The FDA has released guidance that clarifies its suggested approach to the clinical evaluation of software as a medical device (SaMD). The guidance was developed by the International Medical Device Regulators Forum (IMDRF) and is meant to establish “globally harmonized principles” of what evaluation of software is appropriate, based on its potential risk.
In the guidance’s introduction, the IMDRF explained that SaMD typically only processes data collected by other medical devices or biosensors, but clinical decisions are becoming increasingly reliant on this output of data, which has an impact on clinical outcomes. While global regulators expect clinical evaluation of SaMD to match the “scientific rigor” of any other medical device evaluation, authors acknowledged the unique circumstances of software development compared to hardware.
“SaMD, however, is unique in that it operates in a complex, highly connected, interactive socio-technical environment in which frequent changes and modifications can be implemented more quickly and efficiently,” wrote the IMDRF. “Development of SaMD is also heavily influenced by new entrants unfamiliar with medical device regulations and terminology developing a broad spectrum of applications.”
The purpose of the guidance is to outline clinical evaluation methods that would be useful for SaMD and determine the appropriate level of clinical evidence required by SaMD in categories established in a 2014 final guidance. The proposed categories separate different types of SaMD based on the seriousness of the condition they manage, and whether the software is meant to treat or diagnose, drive clinical management, or inform clinical management.
SaMD in categories with the highest amount of potential risk may require independent review, wrote the IMDRF, but the guidance specified that the recommendation of an independent review did not imply that a premarket review authorization (PMA) would be required.
IMDRF suggested several approaches to the collection of clinical performance evidence and analytical validity evidence, but regulators noted that unique aspects of SaMD — connectivity and data collection —uniquely positions developers to pursue real-world evidence in post-market evaluations.
The proposed guidance was presented last month by the IMDRF management committee, following a presentation by Bakul Patel, associate center director for digital health at FDA’s Center for Devices and Radiological Health (CDRH), according to the Regulatory Affairs Professionals Society (RAPS). IMDRF’s goal is to reduce differences among regulatory agencies, and the forum’s current members include regulatory officials from U.S., E.U., China, Japan, Russia, Canada, and Brazil.
The guidance will be available for comments for the next sixty days, at which time both the FDA and IMDRF will develop a final guidance. In remarks published in the Federal Register, the IMDRF outlined a list of questions that industry and regulatory representatives may choose to address with their comments.
For example, the IMDRF welcomes comments regarding additional clinical evaluation approaches that the document did not cover, or other types of SaMD that were not addressed. The forum also asked if there were any possible “adverse consequences” of the proposed regulatory framework that regulatory agencies had not considered.