Should your medical device company address biocompatibility? The short answer is, yes. Every single medical device should conduct some level of biocompatibility testing. What’s important is that you understand to what extent.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about biocompatibility of devices, the applicable FDA and ISO guidelines companies need to follow, and the possible ramifications if you don’t.

Some of the highlights of the show include:

Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin: FDA Draft Guidance is new, but doesn’t cover any new content. FDA’s intent is to clarify the types of biocompatibility information in submissions for certain devices made from common polymers and fabrics that come in contact with intact skin.

What is biocompatibility testing? If you don’t know, that’s why regulation and guidance is necessary. Nobody knows everything, recognize what you don’t.

ISO 10993 Evaluation and Testing: Review guidance, educate yourself, and engage experts because objective evidence is needed to corroborate the case for biocompatibility.

FDA’s Recommendations for Biocompatibility:

List device materials with direct/indirect skin contact and statement comparing/confirming safe use of those materials.

Provide history and clinical study reports of adverse effects/events of skin contact materials, such as redness, swelling, irritation, allergic responses.

Documenting sponsorship determining where biocompatibility risk and testing is not necessary, such as purchasing controls.

Using labeling to mitigate risk of possible skin reactions.

Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: FDA Final Guidance raises special considerations for thermomechanical behavior and processing sensitivity of nitinol when compared to conventional metals.