FDA Software Premarket Submissions

This topic contains a number of FDA guidances and SoftwareCPR training aides related to preparation of software information in premarket submissions for FDA including 510(k)s, PMAs, and IDEs.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 4-6, 2020

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