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.

• Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin (Draft, Oct, 2020)
• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" [Finalized Sept, 2020]
• Final Guidance: Technical Considerations for NonClinical Assessment of Medical Devices Containing Nitinol (Oct 15, 2020; draft issued April 2019)
• Mike on Medtech: FDA's Material Evaluation (April 2, 2019)
• Mike on Medtech: Biomaterials, Biocompatibility, and Bioabsorbable (July 25, 2017)

 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 [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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