FDA’s New Guidance’s Deciding When to Submit a 510(k) for Device and Software Changes

Control of medical device changes and a current 510(k) are big issues in recent FDA studies. Companies are held fully responsible for deciding when a new 510(k) filing is warranted. Often this is a difficult decision process. Effective change control and the power of current risk management tools must be a major part of such an analysis.

The U.S. FDA had published two New Guidance Documents, “Deciding When to Submit a 510(k) for a Change to an Existing Device”, 1) on the device itself, and 2) on device software. These documents attempt to provide companies tools to perform meaningful, results driven 510(k) / change analysis activities. This is part of a growing push by the Agency to strengthen the 510(k) process. The addition of simple tools will assist companies in implementing formal, documented, repeatable methods with defensible rationale for their decisions on when one or several changes may require a new 510(k) submission.

Why You Should Attend:

This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA’s two new Guidance documents on 510(k) Device and Software changes. It will discuss how companies can best document their decisions – whether or not a new 510(k) filing is warranted. It will assist in the implementation of formal methods with documented and defensible rationale; which will also prepare industry for further 510(k) changes in the future. This applies to companies in the medical device and combination products fields. The new guidance will provide manufacturers with a greater understanding of the FDA’s expectations in the current regulatory environment.

Areas Covered in the Session :

  • Key elements of U.S. FDA’s new Guidance on Deciding When to Submit a 510(k) for a Change to an Existing Device
  • Key elements of the U.S. FDA’s new Guidance on Deciding When to Submit a 510(k) for a Software Change to an Existing Device
  • Impact on now replaced U.S. FDA 510(k) Memorandum K97-1 on Deciding When to Submit a 510(k) for a Change to an Existing Device
  • How might these guidance documents affect current device change decisions and 510(k) submissions
  • What approaches can companies use at present, and the Agency’s expectations
Who Should Attend:

  • Research and Development Departments
  • Quality Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Software Engineers
  • Senior management in Devices and Combination products
  • All others tasked with device change analysis and device submissions to the U.S. FDA


Carolyn Troiano

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.



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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance