22
May
2019

FDA Pre-Cert Test Plan Recruiting

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FDA announced the next phase of its Pre-Cert Test Plan implementation. Pre-Cert refers to the the pre-certification program that FDA’s Digital Health unit has been piloting. The program targets SaMD devices only at this time.

This next phase seeks SaMD companies, willing to volunteer, that foresee a De Novo request or 510(k) submission within the next year.   In January of 2019, FDA shared a high level view of the Test Plan which outlines a framework for safety and efficacy of SaMD products through pre-appraisal of processes and methodologies for software validation. This next phase is the latest iteration by FDA in developing the Pre-Cert framework.

About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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