May 24, 2019

The US Food and Drug Administration has called for test cases from developers for its nascent Pre-Cert certification program for software as a medical device (SaMD).

FDA’s request for test case submissions follows the rollout of the Pre-Cert program’s test plan earlier in 2019 establishing processes for evaluating safety and effectiveness of SaMD products. The agency is specifically interested in test cases from developers planning 510(k) or De Novo premarket applications for SaMD products by the end of this year.

Selection criteria for Pre-Cert test cases

On a rolling basis, FDA plans to select Pre-Cert test-case participants according to several criteria:

  • The company intends to submit a 510(k) or De Novo Request for a SaMD product before June 2020;
  • The company does not have any outstanding FDA compliance issues on record;
  • The company has an established track record developing and testing software products using processes measured and monitored using key performance indicators;
  • The company agrees to provide access to key performance indicators; collect real-word post-market performance data; participate in real-time consultations with and Excellence Appraisal site visits from FDA; and provide quality management system data;
  • The company identifies when it anticipates readiness to undergo an Excellence Appraisal by FDA.

Companies interested in volunteering for FDA Pre-Cert test case participation should email statements of interest to the regulator.

Reminder: Pre-Cert and Excellence Appraisals

FDA established the Pre-Cert program as a voluntary US market registration pathway intended to more effectively determine safety and effectiveness as SaMD compared to more conventional medical device premarket review processes.

Although the program remains in pilot mode and FDA does not foresee formal precertification of any SaMD in 2019, the agency intends to conduct Excellence Appraisals of pilot participants; the five criteria used to pre-certify companies include patient safety, SaMD product quality, clinical responsibility, cybersecurity responsibility and proactive culture.

Additional US FDA regulatory resources from Emergo by UL:

  • Network-connected medical device cybersecurity risk management support
  • US FDA medical device classification consulting
  • Whitepaper: FDA cybersecurity requirements for medical devices


  • Stewart Eisenhart