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FDA Issues Several Draft Guidances Including 510(k) Paradigm, Appeals Process

Monday, January 2, 2012  
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FDA issued numerous draft guidances over the past two weeks addressing various aspects of its proposed action plan. They included:

  • 510(k) Paradigm Draft Guidance
  • Product Code Draft Guidance
  • Draft Guidance on Appeals
  • HUD Draft Guidance

MDMA is currently examining these guidances, and will have a more extensive discussion of their possible impact and what comments should be included for FDA to review on the next FDA Working Group call.

To get copies of the guidances, click here.