How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process 2013

  • 12-13 Dec 2013
  • DoubleTree by Hilton Hotel San Francisco Airport, Burlingame, CA, United States

Description

How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process 2013 is a seminar that covers topics such as:

  • The differences between the Traditional, Special and Abbreviated submissions
  • Where to submit the 510(k) and what to expect with the review and approval process
  • Who is required to submit the application to FDA
  • How to locate a "predicate" device and go through the content and format of the 510(k)
  • The De Novo process and the expectations for possibly marketing a low risk device
  • When it is and is not required if you are a device company
  • Exemptions to the submission process and special considerations
  • Substantial Equivalence and how it is applied
  • The potential impact of FDA`s proposed changes to the 510(k) process and why manufacturers need to pay attention

Past Events

Important

Please, check "How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Pharma
Industry: Food & Beverages

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