Sep 16, 2020

The US Food and Drug Administration has issued a new report on progress as well as next steps for its ongoing pilot program to develop a new certification framework for Software as a Medical Device (SaMD).

FDA’s updates on the agency’s Software Precertification (Pre-Cert) Program summarizes key findings from the program’s pilot phase, as well as the implications of these findings for further development efforts:

  • “Mock” Excellence Appraisals of SaMD products based on remote work as well as objective evidence may effectively substitute for on-site visits;
  • The program’s Streamlined Review component for qualifying SaMD requires additional examination and testing;
  • Collecting and examining real-world performance data enables observation of measures including human factors engineering and usability, safety and risk management, but further testing is required to support assessing health benefits using such data.

What comes next for Pre-Cert development

Following FDA’s testing activities carried out with participating companies including Apple, FitBit, Johnson & Johnson and Samsung, the regulator plans additional iterative and revised testing approaches for the Pre-Cert program.

Among these next steps are utilizing a draft library of key performance indicators (KPIs) to further develop and test “excellence thresholds” for Pre-Cert program participants, as well as establish test scenarios for least-burdensome methods for setting safe and effective total product lifecycle processes for SaMD products.

Regarding the Streamlined Review framework whereby Pre-Cert participants obtain expedited US market access, FDA plans further analysis of data collected via Excellence Appraisals, premarket review determinations and real-world performance monitoring to establish relevant criteria.

Overall, FDA is now shifting efforts toward integration of key Pre-Cert program components including Excellence Appraisals, review determinations, Streamlined Review and real-world performance as well as developing a deeper understanding of how these components function as whole.

Additional US FDA medical device and SaMD regulatory resources:

  • US FDA medical device classification consulting
  •  Regulatory consulting for telehealth and mobile medical apps
  • Whitepaper: Overcoming common compliance issues for medical software


  • Stewart Eisenhart