18983288589(微信同号)
18983288589(微信同号)
18908392210(微信同号)
18980413049
2021-12-23
FDA-2021-D-1118
指导原则
美国
现行有效
/
美国食品药品监督管理局(FDA)
GUIDANCE DOCUMENT
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2021-D-1118
The FDA encourages all stakeholders to comment on the following topics:
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this draft guidance to provide its recommendations and expectations to manufacturers of devices that fell within enforcement policies to transition back to normal operations when the public health emergency expires. FDA believes the policy set forth in this guidance may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and processes.
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