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42 rows where docket_id = "FDA-2020-D-1138" sorted by posted_date descending
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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 |
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CREATE TABLE documents (
id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT,
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;