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Software Fast Track? US FDA Asks Developers To Envision 'Precheck' Program

Developers of "software as a medical device" are unique to other device-makers in how fast their products are developed and updated. FDA digital health leader Bakul Patel is asking companies to provide input on the agency's idea for an expedited pathway for software that would be based on established trust.

train fast run on railway track in sunny day

Companies making software that qualifies as a medical device could one day have access to a special fast-track FDA review pathway, but, first, the agency wants input from stakeholders on what such a pathway should look like. If all goes well, the concept could even be applied to products beyond "software as a medical device" (SAMD).

FDA officials have recently been discussing how to deal with unique challenges of product development faced by makers of SAMDs. The matter has been a strong focus among regulators globally. FDA recently issued an International Medical Device Regulators Forum consensus guideline as a draft guidance on SAMDs clinical evaluation. (Also see "US FDA Plan For Adopting International Software Guideline Draws Industry Concern" - Medtech Insight, 10 January, 2017.) But there are particular considerations within the US

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