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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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29 rows where docket_id = "FDA-2020-D-1138" and posted_year = 2020 sorted by posted_date descending

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posted_year 1

  • 2020 · 29 ✖

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1138-0135 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;