Posted By
Tabassum Naqvi
17-Jun-2020 09:46
Found In
Egroup:
Regulatory Open Forum
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Thanks and appreciate your response. All are immuno-assays (with different detection technology) and are 510K exempt. My question is whether we need to submit technical data (bench testing) to FDA for registration to FURLS. Can you please share any websites for registration in Canada,Brazil ...
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