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ARTICLE · 11 MAY 2018

FDA Issues A Working Model For Software Precertification

Finnegan, Henderson, Farabow, Garrett & Dunner LLP
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FDA recently issued an initial working model for its Software as a Medical Device ("SaMD") Precertification Program.

United StatesFood, Drugs, Healthcare, Life Sciences
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
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FDA recently issued an initial working model for its Software as a Medical Device ("SaMD") Precertification Program. The model consists of four program components and is aimed at enabling streamlined oversight of trusted SaMD manufacturers. It will be tested with the help of the nine participants enrolled in the Software Precertification Pilot Program, which was implemented in 2017 to establish a more efficient, risk-based approach to regulating digital health technology and to foster innovation in the digital health space.

The first component of the working model involves an "excellence appraisal" and certification process for SaMD manufactures. Initial precertification for eligible businesses will be evaluated on five principles: commitment to developing and maintaining high quality SaMD products, patient safety, clinical responsibility, cybersecurity protection, and proactive approaches to identifying user needs. FDA envisions two tiers of precertification and an

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