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

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $295.00
  • Refund Policy

Overview:

This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health.

Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Also described will be the type of activities a company can pursue while waiting for submission clearance.

Areas Covered in the Session:
  • When to submit a 510(k) for a new or modified product
  • Types of 510(k) submissions and when to use each
  • What is the submission process
  • What is contained in a 510(k) submission package
  • How to know whether clinical data is required
  • How is the submission package assembled
  • User fees and 510(k) submissions
  • How to interact with the FDA and the reviewer
Who Will Benefit: This webinar will provide valuable assistance to all medical device companies that prepare 510(k) submissions. The employees who will benefit include:
  • Executive Management
  • Regulatory Management
  • Professionals involved with premarket notification to the FDA
  • R&D personnel involved in approving the design of medical devices
  • Sales personnel involved in approving the marketing of medical devices
Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of consumables and instrumentation in the endoscopy field. Among his responsibilities is multi-facility oversight of the CAPA system. In his 20+ years of Quality and Regulatory management, Jeff has implemented and overseen document control systems at all sizes of company, from startup to $100 million in revenue. Over that time, he has also been primary liaison with FDA inspectors and notified body auditors. Jeff received his regulatory affairs certification in 1996, and his certified quality management certification in 2013.


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