FDA uses "particular" in the colloquial dictionary sense. FDA defines "material" as "the substance or substances of which a thing is made or composed". An example of a particular material is 316L stainless steel. Some other common examples are polypropylene and polyethylene. When identifying a subject device's particular materials, I like to identify each material using its CAS number, its basic material name, and any proprietary trade name(s). The trade name is generally given by the material manufacturer.
Here's a narrative from FDA you might find helpful:
"...Some devices are made of materials that have been well characterized both chemically and physically in the published literature and/or have a long history of safe use in legally marketed medical devices. It may not be necessary to conduct testing for all or a portion of the biocompatibility endpoints suggested in the FDA matrix of this guidance. For example, if the sponsor is able to document the use of a particular material (e.g., 316L stainless steel) in a legally-marketed predicate device or a legally-marketed device with comparable tissue exposure, and is able to explain why manufacturing is not expected to adversely impact biocompatibility, additional testing may not be necessary to address some or all of the biocompatibility endpoints recommended for consideration in Attachment A. Sponsors may also leverage information from existing marketing applications to support a rationale that the biocompatibility of the device has been established.28Refer to Section III, Risk Management for Biocompatibility Evaluations, for additional information on how to use prior information in lieu of new testing. Also, refer to Attachment F, Component and Device Documentation Examples, for additional information on comparisons to a legally-marketed device..." This comes from FDA's September 2023 biocompatibility guidance document.
Check out FDA's biocompatibility guidance webpage for further information.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 24-Mar-2024 01:25
From: Anonymous Member
Subject: Particular Materials identification for Biocompatibility
This message was posted by a user wishing to remain anonymous
FDA eSTAR template requires sponsors to state the exact name and any identifiable information for the particular material used in the tissue contacting materials of the medical device.
- How does FDA define particular materials?
- What materials are considered as particular materials?
- Is there a list that FDA has or widely used in industry which we can use to see if we have any particular materials?
- If we have a particular material, how does that impact FDA's review? Do they expect the sponsors to do something different than the applicable tests per ISO 10993-1?
Any help is appreciated. Thanks!