Biocompatability Clinical Evaluation Report

E

eileenr

Hello all,
I am writing a clinical evaluation report for the first time, and I am finding it hard to prove that PEG 20K is biocompatible. Does anyone know of any lists that would tell me that this component is in fact biocompatible. I have been looking on the GRAS list but I can not find that it has been approved in other products, can anyone help me out please.
Kind regards
Eileen:):thanx:
 

Ronen E

Problem Solver
Moderator
Hello all,
I am writing a clinical evaluation report for the first time, and I am finding it hard to prove that PEG 20K is biocompatible. Does anyone know of any lists that would tell me that this component is in fact biocompatible. I have been looking on the GRAS list but I can not find that it has been approved in other products, can anyone help me out please.
Kind regards
Eileen:):thanx:

Biocompatibility is typically established based on intended use, i.e. nature of contact (tissue type) and duration of contact, so I wouldn't expect a "generic" clearance.

You could resort to asking NAMSA (no affiliation) or equivalent.

Cheers,
Ronen.
 
E

eileenr

Hi Ronan E
Thank you for helping me, I am new to this and its a steep learning curve. The company has done some clinical trials using their product and there have been no adverse effects, so I will mention that but in some components using Toxnet and ChemIDPlus has shown that they are safe, There is evidence to show that the lower molecular weight PEGs are safe but am struggling to show that the higher molecular weight PEG is safe in places other than the trials.
Thanks so much for your help I really appreciate it.
Eileen
 
E

eileenr

Hi Ronan
Its a bone cement. I have found some approvals for PEG20000 on the GRAS list, that will work.
regards
Eileen
 
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