AAMI TIR48:2015(R2021)
Superseded
View Superseded by
Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products
English
03-26-2021
05-02-2024
This Technical Information Report (TIR) provides recommendations on the application of CGMPs for drugs, devices, biologics, and human cells, tissues, and cellular and tissue based products during development and marketing of combination products (drug-device, biologic-device, drug-biologic, or drug-device-biologic), in accordance with the FDA’s final rule (21 CFR Part 4; 78 FR 4307, 2013—hereafter "The Rule" or "FDA's Final Rule").
| DocumentType |
Technical Report
|
| ISBN |
978-1-57020-590-3
|
| Pages |
28
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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