Device Changes, FDA Changes, and the 510(K)

Overview:

This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).

Consideration of the U.S . FDA's two current guidance documents, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a [Software} Change to an Existing Device", will provide tools to document such decisions. These analysis must be done for

• Each change
• All cummulative changes collectively, documented

Why should you Attend: 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 Guidance Documents, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change [and Software Change] to an Existing Device", onOctober 25, 2017, which 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, decision trees and questions, will assist companies in implementing formal, documented, repeatable methods with defensible rationale for their decisions on when a new 510(k) submission is required.

Areas Covered in the Session:

• Current FDA Expectations
• Key requirements of the two Guidance Documents on Changes and the 510(k)
• Expected sources of information for evaluation and inclusion
• Approaches to the use of the FDA's two Guidance Documents
• Step-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials Changes
• Change reporting "tipping point" with one change or cumulative
• Which of the three major 510(k) formats should be used
• How to complete, document and control as a 'living' document

Who Will Benefit:

• Senior Management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering
• All personnel tasked with new and changed product development and documentation