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.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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