Digital Health During Pandemic (FDA), Emergency Order Umbrella Order

2020 FDA 0415 Enforcement Digital Health Pandemic 12pp.pdf

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-digital-health-devices-treating-psychiatric-disorders-during-coronavirus-disease


Source Document for Urgent Orders
2020 FDA 0325 Process for Emergency Guidances and Rules 85FR16949 2p.pdf

https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf


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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2020–D–1136, FDA– 2020–D–1137, FDA–2020–D–1138, FDA– 2020–D–1139, FDA–2020–D–1140, FDA– 2020–D–1141, FDA–2020–D–1142, and FDA– 2020–D–1143] Process for Making Available Guidance Documents Related to Coronavirus Disease 2019 AGENCY: Food and Drug Administration, HHS. ACTION: Notice.


 I. Background
On January 31, 2020, as a result of
confirmed cases of COVID–19, and after
consultation with public health officials
as necessary, Alex M. Azar II, Secretary
of Health and Human Services, pursuant
to the authority under section 319 of the
Public Health Service Act (42 U.S.C.
247), determined that a public health
emergency exists and has existed since
January 27, 2020, nationwide.fn1

On March 13, 2020, President Donald J.
Trump declared that the COVID–19
outbreak in the United States constitutes
a national emergency, beginning March 
1, 2020.fn2

FDA is committed to providing 
timely recommendations, regulatory 
advice, guidance, and technical 
assistance on an Agency-wide basis on 
issues related to COVID–19, including 
to clarify our expectations regarding 
regulatory requirements to support 
response efforts to this emergency. To
this end, FDA is announcing procedures 
for making available FDA guidance 
documents related to the COVID–19 
public health emergency. FDA believes
that these procedures, which operate
within FDA’s established good guidance
practices regulations, will allow the
Agency to rapidly disseminate Agency 
recommendations and policies related 
to COVID–19 to industry, FDA staff, and 
other stakeholders.


II. Procedures for Making COVID–19-
Related Guidance Documents Available


To facilitate issuance of guidance on
topics related to the COVID–19 public
health emergency, the Agency intends
to use the following procedures:
• In light of the need to act quickly
and efficiently to respond to the
COVID–19 public health emergency,
FDA anticipates that prior public 
participation will not be feasible or 
appropriate before FDA implements 
COVID–19-related guidance documents. 
FDA anticipates it will issue COVID–19-
related guidance documents for
immediate implementation without
prior public comment (see section
701(h)(1)(C) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
371(h)(1)(C)) and 21 CFR 10.115(g)(2)
(§ 10.115(g)(2)).

• Although FDA expects that COVID–
19-related guidances will be
implemented without prior comment,
FDA will solicit comment, review all
comments received, and revise the
guidance documents as appropriate (see
§ 10.115(g)(2)). Each guidance will
specify the docket number(s) to which
comments can be submitted.

• Guidance documents related to
COVID–19 will be accessible on the 
internet from the FDA web page entitled 
‘‘Coronavirus Disease 2019 (COVID– 
19),’’ available at https://www.fda.gov/ 
emergency-preparedness-and-response/ 
mcm-issues/coronavirus-disease-2019-
covid-19.

• Guidance documents related to
COVID–19 may also be accessed from
the FDA web page entitled ‘‘Search for
FDA Guidance Documents’’ available at
https://www.fda.gov/regulatory-
information/search-fda-guidance-
documents.

• Rather than publishing a separate
Notice of Availability (NOA) for each
COVID–19-related guidance document,
FDA intends to publish periodically a 
consolidated NOA. This periodic NOA
will announce the availability of all the
COVID–19-related guidance documents
that issued during the relevant period.
The consolidated NOA will provide
instructions to the public on submitting
comments on COVID–19-related
guidance documents, including the
docket number(s) associated with each
guidance document, information on
how to view the dockets, and
instructions for persons interested in
obtaining a copy of a COVID–19-related
guidance document. In addition, the
guidance document will provide
information to the public on submitting
comments on the guidance document,
including the docket number(s)
associated with the guidance document
and instructions for persons interested
in obtaining a copy of a COVID–19-
related guidance document.

• FDA intends to establish one docket
for each Center or Office that may issue
COVID–19-related guidance documents.
All COVID–19-related guidance
documents issued by that Center or
Office will be available in the docket

associated with the Center or Office that
issues the guidance document. The
docket numbers associated with each
Center or Office that may issue COVID–
19-related guidance documents are as
follows:

( ^ Centers of FDA, plus Docket Numbers)


Dated: March 20, 2020. 
Lowell J. Schiller, 
Principal Associate Commissioner for Policy. 
[FR Doc. 2020–06222 Filed 3–20–20; 11:15 am]
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