What aspects of the ASR regulation ensure consistency of the product?

Исследователь смотрит на пробирку с жидкостью

ASRs are subject to medical devices reporting and general FDA oversight, which provide guidelines to medical device companies and also help the FDA to keep track of effectiveness and safety of clinical products. Another aspect of the regulation that contributes to product quality is that all ASRs must be manufactured under current Good Manufacturing Practices (cGMPs).