Webinars >>FDA Regulations
New 510k for Modified 510k-Cleared or 510k-Exempt Devices: Best Practices
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:
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:
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