FDA Instrument with combined functions guidance.

FDA’s Office of In Vitro Diagnoitics issued a final guidance November 12, 2014 entitled “Molecular Diagnostic Instruments with Combined Functions”. It discusses the distinction between functionality being submitted to FDA for approval/clearance versus functionality that would not be regulated as a medical device. In addition to general information it contains some new specifics on dealing with software (embedded or standalone) where some of the software in the instrument is for regulated functions and some is not. It discusses the need for design controls and labeling to ensure safety and effectiveness when including combined functions.
Section V.1 recommends that regulated software be separated from other software possibly using dual boot design. Section V.3 talks about software related human factors such as greying out unapproved/uncleared functionality when in regulated mode. Section V.5 recommends that FDA be notificated of any changes to software (regulated or unregulated) that could affect the regulated functionality.

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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