New 510k for Modified 510k-Cleared or 510k-Exempt Devices: Best Practices

Date: April 11, 2025
Duration: 60 Minutes
Time: 12 PM EST

FDA requires the filing of new 510(k) application for devices that are significantly modified from the previously 510k-cleared devices. Not only that, 510k-exempt devices may need 510k-clearance if modified in a way that exceeds the limitation of the exempt status. Many companies make assumptions regarding the testing needed, documentation requirements, and when a new 510k is needed for an “old” device leading to non-compliance, recalls, Warning Letters and other penalties. Often held misconceptions are that if the device is being improved from the previous version, it does not require a new 510k, or that 510-exempt devices stay exempt even after modifications. FDA requires companies to conduct comprehensive testing to determine the need for a new 510k. Recent FDA guidance documents describe the agency’s expectations and interpretations of the regulations for when a new 510(k) is needed for a modified device.

Areas Covered in the Session:

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

Why should you attend:
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.

Who will benefit:
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

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

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Cancellations & Substitutions:

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.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.