AAMI TIR48:2015(R2021)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products
Hardcopy , PDF
02-05-2024
English
26-03-2021
Important note : All end users must be registered with an Account prior to user licenses being assigned.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Superseded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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