A Regulatory Perspective: FDA's New Guidance's Deciding When to Submit a 510(k) for Device & Software Changes
Duration: 75 Minutes
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 has published two New Guidance Documents in October 2017, "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.
Objectives of the Presentation
Why Should you Attend
- Background on 510(k) device modifications
- Important changes in device and software modification guidances
- Common software changes that might require a 510(k) filing
- General guidance highlights
- Software guidance highlights
- Case study analysis on instances requiring/not requiring a new 510(k)
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.
Who will Benefit
- Key elements of U.S. FDA's new Guidance on Deciding When to Submit a 510(k) for a Change to an Existing Device, released October 25, 2017
- 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, also released October 25, 2017
- 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, in effect since January 10, 1997
- 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
- Senior management in Devices and Combination products
- Software engineers
- All others tasked with device change analysis and device submissions to the U.S. FDA