The 510(K) Submission: Requirements, Contents, and Options

Jeff Kasoff
Jun 23, 2020 - 01:00 PM EDT
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The webinar will discuss the 510(k) submission process, the contents required by the Food and Drug Administration (FDA) and understanding of the common pitfalls, additional information request, and potential preventive measures. 

Course Objective

This 510(k) training will provide an understanding of how to get a medical device requiring a 510(k) submission to market as quickly as possible. This presentation will describe the 510(k) submission process and the contents required by the FDA for a successful submission. The webinar will provide an understanding of the common pitfalls, additional information request, and potential preventive measures. Moreover, the presentation will describe the type of interaction a manufacturer can pursue while awaiting for FDA approval. 

Course Outline

  • What should be included in a 510(k) submission
  • Documenting use of standards in 510(k) submissions 
  • Who must submit a 510(k)?
  • Who is not required to submit a 510(k)?
  • Information requested in 510(k)
  • Clinical Data in 510(k)
  • Request for additional information and RTA Checklist 
  • Substantial Equivalence or Substantially Equivalent 

Target Audience

This webinar is designed for regulatory affairs professionals in medical device industry who are tasked with managing regulatory projects and project teams, including:
  • Regulatory Affairs Professionals
  • Quality Assurance and Control Engineers
  • Executive Management
  • Professionals involved in approving the design of medical devices 
  • Marketing and sales personnel involved in approving the marketing of medical devices 

Webinar Events
Attend Live Webinar
Jun 23, 2020 - 01:00 PM EDT

Duration: 60 Minutes

Single Attendee

Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version

Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Jeff Kasoff,

Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

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