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510(k) Change Analysis: Complying with FDA’s Final Guidances
510(k) Change Analysis Complying with FDA’s Final Guidances
510(k) Change Analysis: Complying with FDA’s Final Guidances breaks down the guidances finalized in October, 2017 — Deciding When to Submit a 510(k) for a Change to an Existing Device and Deciding When to Submit a 510(k) for a Software Change to an Existing Device — and provides a step-by-step method for making the right call for submitting a new 510(k) application. Expert-developed spreadsheets walk you through the questions you must ask and lead you to the proper conclusion.
After reading this book, you’ll understand:
What kinds of changes trigger the need for a new 510(k) application and which don’t
How to evaluate the effect of the change on the device’s safety and effectiveness
How to assess the risk the change may introduce
The components of risk as described in ISO 14971
How to follow the complex flowcharts the guidances present
How to develop a risk matrix
How to document the decision-making process, including justifying a decision not to file a new 510(k)
In addition to the decision-making spreadsheets that all but do the work for you, the report includes copies of both guidances and an example of a change analysis effort.
Order your copy of the 510(k) Change Analysis brief for step-by-step instruction on deciding whether you need to submit a new 510(k) if you change an existing device.
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Who Will Benefit
Design Project Managers
Design Engineers
Documentation Specialists
Regulatory Affairs Specialists
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