The proposed voluntary program is for review of “software-as-a-medical-device” products, or SaMD – software that is “intended to treat, diagnose, cure, mitigate or prevent disease or other conditions.” Today, such software faces the same regulatory review as medical device hardware.Examples of SaMD range from software that allows a smartphone to view images obtained from a MRI for diagnostic purposes to computer-aided detection software used to help detect breast cancer.The FDA says its current regulation of medical device hardware “is not well-suited for the faster, iterative design, development, and type of validation used for SaMD,” according to the agency’s draft “working model” document spelling out its proposals.

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