Deciding When to Submit a New 510(k) for a Change to an Existing Device (1.5 hours)

To address some confusion surrounding the guidance Deciding When to Submit a New 510(k) for a Change to an Existing Device, the FDA has worked diligently to enhance predictability, consistency and transparency while maintaining a “least burdensome approach.” The new updated guidance provides greater detail of the regulatory framework, policies and practices underlying FDA’s decision-making process and provides much needed clarity for industry on FDA’s expectations.

In this course we walk through these changes and discuss how to determine when to submit.

Key learning objectives:

At the end of this NSF 510(K) training, you will be able to:

• Identify the guiding principles behind this FDA guidance
• Apply FDA's logic scheme in the decision-making process
• Recognize how to implement principles of risk management and design control in maintaining compliance
• Recognize the importance of documentation, particularly in cases where a new 510(k) is NOT required
• Identify methods to avoid common mistakes in deciding when to submit a new 510(k)
• Identify ways to make informed decisions regarding software modifications

This course is vital for any medical device quality professional including quality directors, managers, engineers and auditors responsible for implementing a quality management system in accordance with ISO 13485:2016 or planning to undergo an MDSAP audit.