The FDA’s guidance document on the use of ISO 10993-1 was updated this month with some crucial information for medical device manufacturers. Biocompatibility testing has been a long-standing requirement for a majority of device manufacturers, so this update that includes some excluded materials and devices is a welcome change.
The most critical update to this guidance is the inclusion of certain materials that can be excluded from the requirements of biocompatibility testing, if they only come into contact with in-tact skin. There is a fairly substantial listing of both synthetic materials and some natural fabrics that the FDA has identified, including low density polyethylene (LDPE), silicone, cotton fabrics, and silk fabrics.
The FDA has identified these materials as exempt from the biocompatibility requirements due to their long history of safe use in legally marketed devices. This is the agency’s way of enforcing a least burdensome approach for low-risk materials. [1]
Even though these identified materials will be exempt from biocompatibility requirements, there are still going to be documentation requirements for product submissions to ensure that there are controls over these materials. Notably, the FDA will want to see production & process controls as well as purchasing controls information in the product submission in lieu of biocompatibility results.
Additionally, there are exclusions to the exclusions that help manufacturers understand the situations where the listed “safe” materials will still require biocompatibility testing. Some situations that would warrant this include reprocessed single-use devices, devices that come into contract with breached/compromised skin, or devices stored in or containing fluids. These particular situations increase the risk of the device, and thereby would still require evidence of biocompatibility.
Understanding the FDA’s stance on product safety and biocompatibility can be tricky, let the experts at EMMA International help! Contact us today at 248-987-4497 or email info@emmainternational.com to learn more!
[1]: FDA (September 2023) Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” retrieved on 09/18/2023 from: https://www.fda.gov/media/142959/download
