Change, Change, Change: FDA Issues Draft Guidance on When Changes to an Existing Medical Device Require a New 510(k)

Event Details


September 29, 2016

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Recently, the Food and Drug Administration issued a draft guidance to help the medical device industry evaluate when a change to an existing medical device might require a new 510(k) submission. While the draft guidance is not legally binding, and FDA will accept comments, it represents the agency’s current thinking.

Join Alan G. Minsk, Partner and Head of AGG’s Food and Drug Team, for a complimentary, one-hour webinar as he will highlight the following:

  • The underlying law and how we arrived at this point
  • What the draft guidance covers (and doesn’t cover)
  • FDA’s “Guiding Principles”
  • AGG recommendations to better understand FDA’s expectations and maximize regulatory compliance

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