Скачать или смотреть FDA Regulatory Education for Industry (REdI) – Devices and Biologics Track

Presenters in the devices track discuss the following topics: Medical Device Single Audit Program (MDSAP), Public MAUDE Database, Additive Manufacturing, and FDA Review of Class I and II Recalls.

Presenters during the biologics track discuss the following topics: Office of Tissues and Advanced Therapies (OTAT), 21 CFR Part 1271 "Tissue Rule," Advanced Therapies under 351 Pathway, Cellular Therapies, Consensus Standards, and Preclinical Development for Cellular Therapies.

For all conference recordings, visit https://www.fda.gov/drugs/regulatory-...

Agenda: https://www.fda.gov/REdI2021

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