FDA Premarket Clinical Data FAQ Guidance

The FDA published the guidance document “Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions.” The guidance document is in Q&A format, and provides clarifications and recommendations to help stakeholders ensure that studies conducted in the U.S. or foreign countries comply with the new rule and revised regulations.

FDA Website

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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