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How to Prepare and Submit a Bullet Proof 510(k) Submission December 2010

Dec 14, 2010
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Course Description 

A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to Premarket Approval (PMA). There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807, as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this session will address key resources when making critical decisions.

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Learning Objectives 

  • Distinguish between the Traditional, Special, and Abbreviated submissions
  • Describe Substantial Equivalence and how it is applied
  • Determine who is required to submit the "submission" to FDA
  • Determine where to submit the 510(k) and what to expect with the review and approval process
  • Determine where and when it is and is not required if you are a device company
  • Describe exemptions to the submission process and special considerations
  • Locate a "predicate" device and go through the content and format of the 510(k)
  • Describe the De Novo process and the expectations for possibly marketing a low risk device

Who Should Attend 

This webinar will provide valuable assistance and guidance to all medical device companies that are preparing and submitting 510(k)s to FDA for review and approval. The employees who will benefit include:

  • All levels of management and personnel from all departments who desire to learn how this process works
  • QA/QC/Compliance/Regulatory Affairs
  • Marketing & Sales
  • Engineering/Technical Services
  • Consultants
  • Operations and Manufacturing

Instructor 

David R. Dills

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Course Length Time 

1 hour; 12:30 - 1:30 p.m. Eastern

Course Dates 

December 14, 2010

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