510(k): Format and Contents 2013

  • 10 Apr 2013
  • Webinar

Description

510(k): Format and Contents 2013 is a webinar that covers topics such as:

  • Definitions and medical device classification including in vitro diagnostic medical devices
  • Statute(s) and regulations governing 510(k)
  • How to identify a suitable predicate device(s), if any
  • Who should submit 510(k)s and when required to submit 510(k)s
  • Recent changes in the 510(k) program
  • How to demonstrate substantial equivalence
  • Differences in contents of 510(k)s based on products
  • Decision points during 510(k) review
  • How to address the relevant and applicable regulatory requirements
  • How to identify regulatory requirements relevant and applicable to the product(s)
  • How to increase 510(k) submission quality for a product
  • How to present your performance data and clinical data in a succinct, comprehensive manner
  • How to resolve different opinions between the submitter and FDA reviewer(s)
  • How to respond to FDA’s request of additional information

510(k): Format and Contents 2013 brings together:

  • Specialists
  • Regulatory Affairs Associates
  • Directors and VPs · Quality Associates
  • Managers
  • Engineers
  • Specialists
  • Directors and VPs · Compliance Specialists and Officers · Research and Development (R&D) Managers
  • Managers
  • Directors and VPs · Complaint Handling and Risk Management Managers and Directors · Sales and Marketing Managers and Directors · Clinical Affairs Managers and Directors · Site Managers
  • Directors and VPs · Product and Development (P&D) Managers
  • And Consultants · Senior and Executive Management · Legal Counsel · Anyone Interested in learning about 510(k) process and submission
  • Directors

Past Events

Important

Please, check "510(k): Format and Contents" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Pharma

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