Biocompatibility evaluation for Hardware/Interface Components?

planB

Super Moderator
#11
Have also a look into
  • the new FDA draft guidance "Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin", which list ABS as safe material on p.4
  • ISO 10993-1:2018, section 5.2.2 (a), NOTE:
    Some medical devices used in either sterile or non-sterile environments include components
    that can come into contact with a user’s ungloved hands such as human interfaces for electronic
    equipment [...]. If these types of components can be shown to be made from materials in common
    use for other consumer products with a similar nature of contact, no further biological evaluation is
    needed.
Hope this helps,
 
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Kuldeep Singh

Involved In Discussions
#12
Thanks PlanB

Are the draft documents acceptable by notify body?? Second, Document issue by FDA regulatory body, is this acceptable by EU notify body??

I am asking just because, during an audit NB rejected the biological evaluation of material which was accepted by FDA in 510(k).
 

planB

Super Moderator
#13
Kuldeep Singh,

In your biological evaluation, including your ABS material, you take _all_ relevant existing data into account. In this respect, relevant literature and relevant publications of authorities are definitely not only legitimate, but also a preferred basis for an informed documented conclusion, and might also serve as an adequate response to your NB audit finding.

Hope this help,
 
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