The FDA’s Centre for Devices and Radiological Health issued the final results of its Software Precertification Pilot Program, launched in 2017. The pilot program explored a new approach to regulating digital health software technologies based on regulating companies’ internal processes, cultural and organizational standards, instead of the individual apps or devices.
Why it’s Notable:
Findings from the pilot, which were considered positive, demonstrate the potential for the FDA’s framework to address the challenges around regulating rapidly evolving software technologies in the modern medical device landscape, such as clinical decision support software (CDSS) and Software as a Medical Device (SaMD).
However, the report also highlighted the requirement for legislative change, as it is unfeasible to implement the FDA’s proposed software precertification program under the current statutory and regulatory legislation.
Industry Implications:
The new guidance provides clarity on the FDA’s use of enforcement discretion for Software as a Medical Device (SaMD), mobile medical apps and categories of clinical decision support software. These regulatory support tools provide developers of these software with a framework for assessing whether or not their technology is subject to FDA regulation as a medical device.
The Digital Health Policy Navigator, launched to assist the companies in understanding these guidelines is a welcome addition. However, the FDA acknowledged that a statutory authority would be required in order to progress regulatory oversight beyond the pilot.
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