New 510k for Modified 510k-Cleared or 510k-Exempt Devices: Best Practices
Date: April 11, 2025
Duration: 60 Minutes
Time: 12 PM EST
- FDA’s current guidance for assessing new 510k for existing devices
- 10 steps to evaluate new 510k needs for 510k-cleared and 510k-exempt devices
- Impact analysis for proposed modification
- Assessing cumulative effect of changes
- New 510k needs related to changed promotional claims
- Common audit findings
- Best practices for documentation practices and assessment reports
This webinar, presenting by a leading 510k expert will discuss the common errors made by developers of modified 510k devices with potential solutions for each kind of error. The session will highlight key regulatory requirements, dos and don’ts, common areas of concern, and trouble-shooting practices for medical device manufactures using case studies and examples from the presenter’s vast experience helping companies big and small in dealing with 510k need assessment. The webinar will provide precise and complete list of measures and checklists to be implemented by FDA-regulated companies to bullet-proof their 510k assessment.
This webinar will provide valuable assistance to:
- Regulatory affairs personnel
- Quality assurance personnel
- Vice presidents, Directors and Managers
- People interested in investing in the FDA-regulated industry
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
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Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
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