FDA CDRH 510(k) Powered Tables and PT Tables

“Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Powered Tables and Multifunctional Physical Therapy Tables”

This document was issued in July of 1995. It requires software information in 510(K) submissions for these types of devices. As it predates the current FDA software submission guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” it references the now obsolete 1991 submission guidance “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review.” It should be assumed that the correct reference is the current software submission guidance and not the 1991 version. This document stresses that if only the minimum information identified in the software guidance is provided this may not assure adequate information for the 510(k) clearance. It indicates a particular interest in pass/fail and test completion criteria and the functonal test plan as well as information on the development lifecycle and traceability of safety concerns throughout development.

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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