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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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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:
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
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
The FDA encourages all stakeholders to comment on the following topics:
- Whether the 180-day transition period before FDA withdraws the guidances identified in List 1 would sufficiently allow for an appropriate transition period that avoids exacerbating product shortages and supply chain disruptions.
- Suggestions to add or remove guidance documents to or from List 1 of the draft guidance.
- FDA's proposal to extend the effectiveness of the guidances in List 1 of the draft guidance either for 180 days or, if the Public Health Emergency (PHE) declaration under section 319 of the Public Health Service Act expires before the finalization of this guidance, for at least 225 days.
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FDA is issuing this draft guidance to provide its recommendations and expectations to manufacturers of devices that fell within enforcement policies to transition back to normal operations when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.