Preparing and Submit a Compliant 510(k) Submission

OVERVIEW Since September 2009, the Centre for Devices and Radiological Health has been reviewing the operation of the 510(k) program and the way CDRH uses science in the decision making process. In August 2010, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making each released a preliminary report with a series of recommendations. Overall, industry has provided mostly a positive response but with exceptions. The proposals are more benign than many had feared. No radical change to the current process appears likely.

WHY SHOULD YOU ATTEND

This webinar provides an overview of the premarket notification process and all of the critical and key steps required to ensure you prepare and submit a well-constructed 510(k). Provides an overview of the 510(k) Program including the basics of how to prepare and submit a 510(k) to the FDA and recent changes and trends.

AREAS COVERED

• Statutory Requirements and Expectations
• When a 510(k) Is Required and Not Required
• Who is Required to Submit and Who is Exempt
• Device Classification
• Forms Required and to be Used
• Submission Methods: Log-In, Review Process and the Decision Letter
• Traditional/Special/Abbreviated 510(k) Submissions
• Find and Use the Right Predicates

LEARNING OBJECTIVES

This webinar will provide valuable assistance and guidance to medical device and IVD companies involved in any aspect of the 510(k) process.

WHO WILL BENEFIT

• CRO’s
• Regulatory Affairs/RA Specialists
• Clinical Affairs
• Project Leaders
• Quality and Compliance
• Marketing & Sales
• Distributors/Authorized Representatives
• Engineering/Technical Services/Operations
• Consultants

For more detail please click on this below link:
http://bit.ly/2GtHj2y
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882

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