510(k) Change Analysis: Complying with FDA’s Final Guidances

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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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