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

On-Demand1 hour and 30 minutes

Course Overview

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.

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Additional Recommended Courses

Design Controls for Medical Devices and IVDs

This virtual instructor-led two-day course covers design control principles and design and development regulatory requirements relative to U.S. 21 CFR Part 820, ISO 13485:2016 and the EU MDR. Practical examples will be incorporated.

This course covers important requirements for medical device and IVD design controls. Learners will benefit from open dialogue and the sharing of current design and development principles, including the interrelationship of risk management and design and development throughout the lifecycle of a device.  This course includes interactive group activities relative to all phases of design and development.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify key regulatory requirements for risk management
    • European Union
    • Quality System Regulation
    • ISO 13485:2016
  • Identify key principles of ISO 14971:2019
  • Identify key regulatory requirements for design controls:
    • European Union
    • Quality System Regulation
    • ISO 13485:2016
  • Recognize potential exemptions from design control requirements
  • Identify when, during a design and development project, design control requirements apply
  • Conceptualize graphically a design control process

Who Should Attend

This class is vital for any medical device research and development professional, regulatory scientist, and/or clinician involved in developing and manufacturing medical devices. This course provides critical knowledge for both regulatory affairs and quality assurance professionals.

Price: $1200.00