1997 FDA CDRH 510(k) Device Modifications

OBSOLETE: Replaced by Oct. 25, 2017 New guidanceFDA CDRH Guidance for Industry “Deciding when to submit a 510(k) for a change to existing device” issued January 10, 1997. This provides guidance on determining whether a change to previously cleared device requires submission of a 510(k). This guidance provides a series of questions and flowcharts with explanations of things to be considered. Question B8 Identifies software and firmware changes and question B4 identifies changes to the ergonomics of the patient/user interface. If such changes occur then a series of four additional questions need to be answered to determine if the 510(k) is required.

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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