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Regulatory Focus™ > News Articles > 2019 > 5 > FDA Solicits PreCert Software Developer Volunteers

FDA Solicits PreCert Software Developer Volunteers

Posted 22 May 2019 | By Michael Mezher 

FDA Solicits PreCert Software Developer Volunteers

The US Food and Drug Administration (FDA) on Wednesday put out a call for digital health software developers to participate in the agency’s software precertification (Pre-Cert) program as part of its 2019 Test Plan.
FDA first detailed the Test Plan in January, saying its primary purpose is to determine whether the excellence appraisal and streamlined review components of the Pre-Cert program “produce an equivalent basis for determining reasonable assurance of safety and effectiveness for a [software as a medical device] SaMD.”
Now, FDA says it is looking for companies that are planning to submit a de novo request or a 510(k) submission for a SaMD product between now and June 2020 to serve as test cases.
FDA says it is open to a variety of companies, including small and large software developers, companies that produce a range of low- and high-risk SaMD products and companies that “are not considered to be traditional medical device manufacturers but who intend to make SaMD.”
However, because the goal of the Test Plan is to validate aspects of the Pre-Cert model, FDA says it “does not intend to provide precertification for companies during the testing in 2019.”
Other criteria to participate in the Test Plan include being in good standing with the agency with no outstanding compliance actions and having a strong track record in software development, testing and maintenance.
FDA also says that participants must be willing to agree to terms laid out in its Pre-Cert Working Model (v1.0), including providing the agency with data such as key performance indicators, gathering real-world postmarket performance data and making themselves available for consultations and site visits.
FDA says it will accept volunteers for the Test Plan on a rolling basis, and that it will consider “resources and time permitting” companies that volunteer to test individual components of the Pre-Cert program.

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