Mike on Medtech: FDA's Material Evaluation

Mike on Medtech: FDA's Material Evaluation

Sean Fenske and Mike Drues discuss the FDA's announcement that the agency will review materials used in the manufacture of medical devices.

By Sean Fenske, Editor-in-Chief04.02.19
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s letter from March 15, which provided a statement from FDA Commissioner Scott Gottlieb, M.D., and Jeffrey Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions. Specifically, we address a number of questions, including:

  • What were the main contents of this announcement with regard to the evaluation of materials by the FDA?
  • Are there certain materials they are expected to target early in this review process?
  • What are technology-specific guidances and how do they relate to this effort?
  • Will the FDA ban specific materials if they do not meet a certain criteria or have too high an incidence of reactions among patients?
  • Will this effort ultimately lead to a regulatory pathway to approve materials for medical device manufacture?
  • Does having a review process for materials that would be approved for use in medical devices run counter to allowing for a broad selection of materials for a given device and ultimately limit options for innovation?

Listen to this episode and see what you think regarding the FDA’s interest in evaluating medical device materials and/or ultimately establishing a review process for materials. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or you can download the MP3 file, load it onto your player of choice, and listen at your convenience.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

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