id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2020-D-1138-0158,FDA,FDA-2020-D-1138,"Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease
2019 (COVID–19) Public Health Emergency; Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2023-03-27T04:00:00Z,2023,3,2023-03-27T04:00:00Z,,2023-03-27T14:45:55Z,2023-06291,0,0,09000064858691ed
FDA-2020-D-1138-0159,FDA,FDA-2020-D-1138,"Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff",Other,Guidance,2023-03-27T04:00:00Z,2023,3,2023-03-27T04:00:00Z,,2024-11-12T23:53:48Z,,1,0,090000648586991a
FDA-2020-D-1138-0156,FDA,FDA-2020-D-1138,"Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency; Guidance for Industry and Food and Drug Administration Staff",Other,Guidance,2023-03-14T04:00:00Z,2023,3,2023-03-14T04:00:00Z,2023-11-08T04:59:59Z,2023-05-24T21:04:09Z,,0,0,09000064857a50bf
FDA-2020-D-1138-0157,FDA,FDA-2020-D-1138,Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency; Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2023-03-14T04:00:00Z,2023,3,2023-03-14T04:00:00Z,,2024-11-12T23:52:41Z,,1,0,09000064857a5065
FDA-2020-D-1138-0155,FDA,FDA-2020-D-1138,Guidance Documents Related to Coronavirus Disease 2019 (COVID–19),Notice,General Notice,2023-03-13T04:00:00Z,2023,3,2023-03-13T04:00:00Z,,2023-03-13T14:31:19Z,2023-05094,0,0,090000648579c134
FDA-2020-D-1138-0153,FDA,FDA-2020-D-1138,Effects of the COVID–19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices—Questions and Answers (Revised); Withdrawal of Guidance,Notice,Withdrawal,2022-06-07T04:00:00Z,2022,6,2022-06-07T04:00:00Z,,2022-06-07T14:27:51Z,2022-12176,0,0,09000064851456f2
FDA-2020-D-1138-0152,FDA,FDA-2020-D-1138,Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised),Other,Guidance,2022-05-04T04:00:00Z,2022,5,2022-05-04T04:00:00Z,,2024-11-12T23:41:02Z,,1,0,090000648504d501
FDA-2020-D-1138-0149,FDA,FDA-2020-D-1138,Guidance Documents Related to Coronavirus Disease 2019; Availability,Notice,Notice of Availability,2022-01-21T05:00:00Z,2022,1,2022-01-21T05:00:00Z,,2022-01-21T13:45:27Z,2022-01146,0,0,0900006484f2c31e
FDA-2020-D-1138-0150,FDA,FDA-2020-D-1138,"Enforcement Policy for Viral Transport Media During the Coronavirus Disease (COVID–19) Public Health Emergency (Revised); Guidance for Commercial Manufacturers, Clinical Laboratories, and Food and Drug Administration Staff",Other,Guidance,2022-01-21T05:00:00Z,2022,1,2022-01-21T05:00:00Z,2023-11-08T04:59:59Z,2023-05-24T21:14:35Z,,0,0,0900006484f2d339
FDA-2020-D-1138-0147,FDA,FDA-2020-D-1138,"Guidance Documents Related to
Coronavirus Disease 2019; Availability",Notice,Notice of Availability,2021-10-06T04:00:00Z,2021,10,2021-10-06T04:00:00Z,,2021-10-06T15:29:16Z,2021-21798,0,0,0900006484dbc9ed
FDA-2020-D-1138-0144,FDA,FDA-2020-D-1138,"Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised); Guidance for Industry and Food and Drug Administration Staff",Other,Guidance,2021-09-15T04:00:00Z,2021,9,2021-09-15T04:00:00Z,2023-11-08T04:59:59Z,2023-11-07T02:00:58Z,,0,0,0900006484d826cf
FDA-2020-D-1138-0138,FDA,FDA-2020-D-1138,Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus  Disease 2019 (COVID-19) Public Health Emergency; Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2021-01-14T05:00:00Z,2021,1,2021-01-14T05:00:00Z,2023-11-08T04:59:59Z,2023-05-24T21:12:03Z,,0,0,09000064849f2c09
FDA-2020-D-1138-0137,FDA,FDA-2020-D-1138,Guidance Documents Related to Coronavirus Disease 2019; Availability,Notice,Notice of Availability,2021-01-04T05:00:00Z,2021,1,2021-01-04T05:00:00Z,,2021-01-04T14:21:13Z,2020-29058,0,0,09000064849db7ae
FDA-2020-D-1138-0135,FDA,FDA-2020-D-1138,"Enforcement Policy for the Quality Standards of the Mammography  Quality Standards Act During the COVID-19 Public Health Emergency 
Guidance for Mammography Facilities, State MQSA Contract Partners,  FDA-Approved MQSA Accreditation Bodies, and Food and Drug  Administration Staff",Other,Guidance,2020-12-04T05:00:00Z,2020,12,2020-12-04T05:00:00Z,2023-05-12T03:59:59Z,2023-05-09T19:22:22Z,,0,0,0900006484987758
FDA-2020-D-1138-0134,FDA,FDA-2020-D-1138,"Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to
Support Single-User Reuse of Certain Filtering Facepiece Respirators
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry, Healthcare Organizations, Healthcare
Personnel, and Food and Drug Administration Staff",Other,Guidance,2020-11-27T05:00:00Z,2020,11,2020-11-27T05:00:00Z,,2024-11-06T23:42:54Z,,1,0,0900006484976a11
FDA-2020-D-1138-0132,FDA,FDA-2020-D-1138,Guidance Documents Related to Coronavirus Disease 2019; Availability,Notice,Notice of Availability,2020-11-18T05:00:00Z,2020,11,2020-11-18T05:00:00Z,,2020-11-18T13:30:14Z,2020-25399,0,0,0900006484965ca4
FDA-2020-D-1138-0127,FDA,FDA-2020-D-1138,Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2020-10-13T04:00:00Z,2020,10,2020-10-14T04:00:00Z,2023-11-08T04:59:59Z,2023-05-24T21:11:40Z,,0,0,090000648490a841
FDA-2020-D-1138-0123,FDA,FDA-2020-D-1138,Guidance Documents Related to Coronavirus Disease 2019; Availability,Notice,Notice of Availability,2020-09-09T04:00:00Z,2020,9,2020-09-09T04:00:00Z,,2020-09-09T12:57:06Z,2020-19883,0,0,090000648484cb25
FDA-2020-D-1138-0120,FDA,FDA-2020-D-1138,Guidance Documents Related to Coronavirus Disease 2019; Availability,Notice,Notice of Availability,2020-08-03T04:00:00Z,2020,8,2020-08-03T04:00:00Z,,2020-08-03T15:34:07Z,2020-16852,0,0,09000064847ccc09
FDA-2020-D-1138-0111,FDA,FDA-2020-D-1138,"Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19)Public Health Emergency Guidance for Commercial Manufacturers, Clinical Laboratories, and Food and Drug Administration Staff",Other,Guidance,2020-07-20T04:00:00Z,2020,7,2020-07-20T04:00:00Z,2023-11-08T04:59:59Z,2023-05-24T21:14:18Z,,0,0,0900006484788093
FDA-2020-D-1138-0105,FDA,FDA-2020-D-1138,"Guidance Documents Related to Coronavirus Disease 2019 (COVID–19);
Availability",Notice,Notice of Availability,2020-06-26T04:00:00Z,2020,6,2020-06-26T04:00:00Z,,2020-06-26T13:37:30Z,2020-13829,0,0,090000648470facd
FDA-2020-D-1138-0103,FDA,FDA-2020-D-1138,Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2020-06-22T04:00:00Z,2020,6,2020-06-22T04:00:00Z,,2024-11-06T23:37:51Z,,1,0,09000064846ff433
FDA-2020-D-1138-0097,FDA,FDA-2020-D-1138,"Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Guidance for Industry and Food and Drug Administration Staff",Other,Guidance,2020-05-27T04:00:00Z,2020,5,2020-05-27T04:00:00Z,,2024-11-12T23:21:22Z,,1,0,09000064846b2c49
FDA-2020-D-1138-0095,FDA,FDA-2020-D-1138,"Guidance Documents Related to Coronavirus Disease 2019 (COVID–19);
Availability",Notice,Notice of Availability,2020-05-26T04:00:00Z,2020,5,2020-05-26T04:00:00Z,,2020-05-26T13:24:42Z,2020-11238,0,0,09000064846ac68a
FDA-2020-D-1138-0093,FDA,FDA-2020-D-1138,"Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and
Food and Drug Administration Staff",Other,Guidance,2020-05-21T04:00:00Z,2020,5,2020-05-21T04:00:00Z,,2024-11-12T23:20:29Z,,1,0,090000648465f817
FDA-2020-D-1138-0089,FDA,FDA-2020-D-1138,"Guidance Documents Related to Coronavirus Disease 2019 (COVID–19);
Availability",Notice,Notice of Availability,2020-05-12T04:00:00Z,2020,5,2020-05-12T04:00:00Z,,2020-05-12T13:20:56Z,2020-10146,0,0,09000064845cd12b
FDA-2020-D-1138-0083,FDA,FDA-2020-D-1138,"Notifying CDRH of a Permanent Discontinuance or Interruption in
Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency Guidance for Industry and Food and Drug Administration Staff",Other,Guidance,2020-05-06T04:00:00Z,2020,5,2020-05-06T04:00:00Z,2023-05-12T03:59:59Z,2023-05-09T19:21:38Z,,0,0,090000648456bab8
FDA-2020-D-1138-0078,FDA,FDA-2020-D-1138,"Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry, Clinical Laboratories, Healthcare Facilities, Pathologists, and Food and Drug Administration Staff",Other,Guidance,2020-04-24T04:00:00Z,2020,4,2020-04-24T04:00:00Z,2023-11-08T04:59:59Z,2023-05-25T21:14:03Z,,0,0,09000064844d0e91
FDA-2020-D-1138-0076,FDA,FDA-2020-D-1138,Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2020-04-23T04:00:00Z,2020,4,2020-04-23T04:00:00Z,2023-11-08T04:59:59Z,2023-05-24T20:55:17Z,,0,0,09000064844c9284
FDA-2020-D-1138-0077,FDA,FDA-2020-D-1138,"Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and
Food and Drug Administration Staff",Other,Guidance,2020-04-23T04:00:00Z,2020,4,2020-04-23T04:00:00Z,2023-11-08T04:59:59Z,2023-05-24T20:33:31Z,,0,0,09000064844c9287
FDA-2020-D-1138-0070,FDA,FDA-2020-D-1138,Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2020-04-16T04:00:00Z,2020,4,2020-04-16T04:00:00Z,2023-11-08T04:59:59Z,2023-11-06T02:00:31Z,,0,0,09000064844aea0b
FDA-2020-D-1138-0068,FDA,FDA-2020-D-1138,Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2020-04-14T04:00:00Z,2020,4,2020-04-14T04:00:00Z,2023-11-08T04:59:59Z,2023-10-19T01:04:33Z,,0,0,09000064844a4305
FDA-2020-D-1138-0056,FDA,FDA-2020-D-1138,"Enforcement Policy for Extracorporeal Membrane
Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019  COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff",Other,Guidance,2020-04-07T04:00:00Z,2020,4,2020-04-07T04:00:00Z,2023-11-08T04:59:59Z,2023-05-24T20:56:51Z,,0,0,090000648448f8c8
FDA-2020-D-1138-0055,FDA,FDA-2020-D-1138,Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2020-04-06T04:00:00Z,2020,4,2020-04-06T04:00:00Z,2023-11-08T04:59:59Z,2023-05-24T20:59:27Z,,0,0,090000648448f9e5
FDA-2020-D-1138-0053,FDA,FDA-2020-D-1138,Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2020-04-06T04:00:00Z,2020,4,2020-04-06T04:00:00Z,,2024-11-06T23:34:32Z,,1,0,090000648448c9cb
FDA-2020-D-1138-0054,FDA,FDA-2020-D-1138,Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2020-04-06T04:00:00Z,2020,4,2020-04-06T04:00:00Z,2023-11-08T04:59:59Z,2023-10-20T01:04:22Z,,0,0,090000648448ceaa
FDA-2020-D-1138-0023,FDA,FDA-2020-D-1138,"Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff",Other,Guidance,2020-03-30T04:00:00Z,2020,3,2020-03-30T04:00:00Z,2023-11-08T04:59:59Z,2023-11-07T02:00:23Z,,0,0,0900006484477bc8
FDA-2020-D-1138-0022,FDA,FDA-2020-D-1138,"Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff",Other,Guidance,2020-03-30T04:00:00Z,2020,3,2020-03-30T04:00:00Z,2023-11-08T04:59:59Z,2023-05-24T21:06:50Z,,0,0,09000064844775a0
FDA-2020-D-1138-0013,FDA,FDA-2020-D-1138,Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2020-03-26T04:00:00Z,2020,3,2020-03-26T04:00:00Z,2023-11-08T04:59:59Z,2023-11-07T02:01:05Z,,0,0,090000648446be1d
FDA-2020-D-1138-0014,FDA,FDA-2020-D-1138,Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2020-03-26T04:00:00Z,2020,3,2020-03-26T04:00:00Z,2023-11-08T04:59:59Z,2023-11-07T02:00:23Z,,0,0,090000648446be1e
FDA-2020-D-1138-0012,FDA,FDA-2020-D-1138,Process for Making Available Guidance Documents Related to Coronavirus Disease 2019,Notice,Announcement,2020-03-25T04:00:00Z,2020,3,2020-03-25T04:00:00Z,,2020-03-26T13:34:14Z,2020-06222,0,0,090000648446b69d
FDA-2020-D-1138-0001,FDA,FDA-2020-D-1138,"Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and
Food and Drug Administration Staff",Other,Guidance,2020-03-20T04:00:00Z,2020,3,2020-03-20T04:00:00Z,,2024-11-12T23:18:43Z,,1,0,090000648445c9d7