FDA’s Current Rules for Software 510(k) Applications: Evolving Regulations
Date: March 7, 2025
Time: 12 PM EST
Duration: 60 Minutes
Areas Covered in the Session:
- FDA definitions for software in medical devices
- What makes your software a medical device?
- What specific software –related documentation is required?
- Risk Assessment/Mitigation for software related risk in medical device operation
- Software change management and its relationship to risk assessment
- When is a 510(k) needed for Off the Shelf (OTS) software?
- Could the Special 510(k) or Abbreviated 510(k) apply to your application?
- Exemptions to the 510(k) requirements
- Labeling of Software devices
This seminar will provide practical tips and useful suggestions regarding testing requirements and documents to be included in the 510(k) applications for medical device software. Practical strategies for complying with the current rules will be discussed using case studies and examples of scenarios.
Who will benefit:
- Regulatory specialists who compose 510(k) applications for software
- Manufacturers of medical devices
- Product Development managers
- Regulatory managers
- Project managers and documentation specialists
- Medical writers
- Medical device IT specialists
- Medical device and 510(k) consultants
- Import Supervisors
- Customs Brokers
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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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.
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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.
