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Mike on Medtech: Biocompatibility and Nitinol Guidances

Mike on Medtech: Biocompatibility and Nitinol Guidances

Mike Drues and Sean Fenske discuss two FDA guidance documents that focus on biocompatibility and nitinol-containing devices.

By Sean Fenske, Editor-in-Chief10.26.20
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s guidances on biocompatibility submissions and nitinol-containing devices. Although the two are separate guidance documents, we combine them into a single discussion. Specifically, we address a number of questions, including:

  • What is the biocompatibility guidance in regard to?
  • Does this help simplify the pathway to market for commonly used materials that have a proven record?
  • The fact that we’re talking about “intact skin surface,” this wouldn’t apply to any type of wound care products, correct?
  • With the nintinol-containing devices guidance, what’s the purpose behind that?
  • Is this guidance primarily being put out due to the potential for an allergic reaction to nickel or is it more about the unique physical characteristics of Nitinol?
  • What are the primary takeaways from these guidances device makers should keep in mind?

There are also a number of references made. Following are links for more information on those items.


Listen to this episode and see what you think of these two guidance documents and whether they could affect an upcoming product you are producing. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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