We are a 30-year, 200-employee, 25-510(k), FDA registered device maker. We have several thousand products, both standards and OEM stuff. We are constantly developing new product variants for OEM customers, very often involving industrial-class materials, i.e. without pre-existing ISO 10993 biocompatibility classification. An example might be a new flexible urethane film , engineered to meet our specific clinical-performance needs for the OEM project. These products almost always are single use, sterile, and low volume. Often the products in question are Class I, but sometimes Class II.

Sometimes these products have patient contact, in which case the applicability of ISO 10993 is clear. In other cases, the intended use is related to an invasive procedure conducted in a sterile field, and the newly developed device is sold sterile and is used to maintain the sterile field, but the device has zero contact with either the patient or patient-contacting clinical personnel.

Cost control and speed of such product development is always important, and ISO 10993 qualification is expensive and slow for a material used only for a single-use, low-volume product.

Under present FDA regulations, can someone point me to clarification of the requirement for ISO 10993 biocompability qualification of a material that will not have patient contact?

If there is no direct or indirect patient contact, biocompatibility data is not necessarily required, according to the FDA. See Attachment C in their guidance doc, Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 (G95-1)

http://www.fda.gov/cdrh/g951.html

The same applies for ISO 10993 series, BTW.

Regulations aside, however, you should still consider (e.g., in your risk analysis) if there is anything that may be deleterious to anyone handling the device or in the vicinity of the device (allergens, aerosols, etc.) and perform testing if this is a possibility.


-Victoria

Heh. Thank you. So much for my text copy of G95.1, which it turned out didn't include the Appendices. Oops.

Most of the devices in question are incoming-contamination-prevention covers applied to imaging equipment that's used in proximity to invasive processes, i.e. C-arm heads, etc. The most common material is food grade polyethylene film, for which we have a 30-year material-class application record in similar devices with no evidence of harm. That of course wouldn't be a sufficient basis for bypassing ISO 10993 qualification in a patient contact device, but I regard it as sufficient to support a minimal-risk determination for 14971 purposes in a non-contact device. :)