The FDA released version 0.2 of its Developing Software Precertification Program intended to allow the agency to more efficiently approve software as a medical device (SaMD) without risking patient health and safety.
The agency announced a pilot program in July 2017 and in September 2017 named nine participants selected for the pilot, including Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Alphabet’s Verily (IDDM, Oct. 2, 2017).
Participants in the pilot program agreed to provide information on how they develop, test and maintain their software products and on their quality management systems. They also committed to being available for site visits from agency officials.
The FDA released its first working model of the program in April and it flagged the changes in the revised version. The agency plans to review the public docket every two weeks and to further refine the program to reflect the comments in future versions.
Version 0.2 clarifies the definition of SaMD as “software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device.” A SaMD is “capable of running on general purpose (non-medical purpose) computing platforms,” to include smart phones and watches, laptops, glucose meters and infusion pumps. The category includes in-vitro diagnostic (IVD) devices.
Software that is necessary for a hardware medical device to fulfill its intended medical purpose is not considered a SaMD, the agency said. Rather, a SaMD is “software that acts on data for a medical purpose.” Medical devices such as MRI and ECG machines and general wellness devices collect data that can be used as input into a SaMD. Mobile apps that meet these definitions are also considered to be SaMD.
Version 0.2 distinguishes between organizations that have successfully marketed medical products and those that have not. The original version of the program proposed to include only companies that had already successfully marketed and maintained medical devices. However, version 0.2 states that the FDA’s current thinking “reflects the belief that an organization of any size without a medical device or SaMD currently on the market should have the opportunity to deliver products for medical purposes as a pre-certified organization.”
Despite this new thinking, no new companies have been added to the original nine that were selected to take part in the pilot project, FDA spokesperson Stephanie Caccomo told FDAnews.
Version 0.2 also adds new proposed elements for demonstrating excellence in order to obtain program precertification, including new performance indicators.
The FDA is seeking further comments from stakeholders on which elements of the program are likely to “provide confidence that an organization makes high quality products” and how to “provide a least burdensome approach for software organizations to identify their processes/activities and outcomes.”
The agency expects to release version 1.0 of the program by December 2018.
See version 0.2 of the precertification program here: www.fdanews.com/06-21-18-Precertification.pdf. — Donna Scaramastra Gorman