AAMI TIR105:2020
Current
Current
The latest, up-to-date edition.
Risk management guidance for combination products
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
28-09-2020
This TIR provides recommendations on the application of risk management principles and processes during development and marketing of combination products that include a device constituent part (drug−device, biological drug−device, or drug−device−biologic), in accordance with FDA’s final rule (21 CFR Part 4) [11]. 4
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