510k and FDA Requirements

Missing information and deficiencies in your 510(k) submission can lead to failure and may significantly delay your medical device product launch. This course is designed to provide an overview of the FDA’s medical device regulations and teach you how to prepare your 510(k). 

Key topics

• Overview of FDA medical device regulations  
• Medical Device Classification 
• Establishment Registration and Listing 
• Regulatory pathways 
• Types of 510(k) Submissions 
• Preparing a 510(k) submission 
  • Required elements of a 510(k) submission 
  • Concept of Substantial Equivalence 
• Submitting a 510(k): eSTAR guidelines
• FDA 510(k) Review Process  
  • Steps and timelines 
  • Interacting with the FDA during the submission process 
  • Responding to FDA Requests for Additional Information 
• Overview of FDA Medical Device Guidance Documents  
• Walkthrough of FDA Medical Device Databases 
• Q-Submissions 
• 513(g) Request for Information 
• Case studies and best practices 

Course objectives

After this course, participants will have a comprehensive understanding of the FDA 510(k) submission process, enabling them to effectively prepare, submit, and navigate regulatory requirements for medical device clearance. 

Who is the course aimed at?

This course is intended for quality and regulatory professionals working with medical devices, medical device company management and employees who need to learn more about FDA 510(k) submissions. 

Upcoming classes

Please note:

Intertek operates under strict standards of independence, impartiality, and integrity. Read more about how we work here: https://www.intertek.com/about/compliance-governance/