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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

12 rows where docket_id = "FDA-2013-D-1358" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2013-D-1358-0009 FDA None FDA-2013-D-1358 Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation Other Guidance 2015-08-03T04:00:00Z 2015 8 2015-08-03T04:00:00Z   2024-11-12T05:40:35Z   1 0 0900006481bba982
FDA-2013-D-1358-0014 FDA None FDA-2013-D-1358 Reference 15 - Clinical Relevance of the HLA System in Blood Transfusion (2) re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation Supporting & Related Material Background Material 2015-08-03T04:00:00Z 2015 8     2015-08-03T19:03:01Z   0 0 0900006481bbb8d5
FDA-2013-D-1358-0012 FDA None FDA-2013-D-1358 Reference 13 - Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline (2) re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation Supporting & Related Material Background Material 2015-08-03T04:00:00Z 2015 8     2015-08-03T19:02:47Z   0 0 0900006481bbbbd0
FDA-2013-D-1358-0016 FDA None FDA-2013-D-1358 Reference 17 - The HLA System (Part II) (2) re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation Supporting & Related Material Background Material 2015-08-03T04:00:00Z 2015 8     2015-08-03T19:03:13Z   0 0 0900006481bbb8d7
FDA-2013-D-1358-0010 FDA None FDA-2013-D-1358 List of References re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation Supporting & Related Material Background Material 2015-08-03T04:00:00Z 2015 8     2015-08-03T19:02:31Z   0 0 0900006481bbbbcd
FDA-2013-D-1358-0008 FDA None FDA-2013-D-1358 Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Guidance for Industry; Availability Notice Notice of Availability 2015-08-03T04:00:00Z 2015 8 2015-08-03T04:00:00Z   2015-08-03T16:05:21Z 2015-18956 0 0 0900006481bb9559
FDA-2013-D-1358-0015 FDA None FDA-2013-D-1358 Reference 16 - The HLA System (Part I) (2) re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation Supporting & Related Material Background Material 2015-08-03T04:00:00Z 2015 8     2015-08-03T19:03:07Z   0 0 0900006481bbb8d6
FDA-2013-D-1358-0017 FDA None FDA-2013-D-1358 Reference 18 - The Human Leukocyte Antigen System (2) re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation Supporting & Related Material Background Material 2015-08-03T04:00:00Z 2015 8     2015-08-03T19:03:23Z   0 0 0900006481bbb8d8
FDA-2013-D-1358-0011 FDA None FDA-2013-D-1358 Reference 9- IMGT Home page re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation Supporting & Related Material Background Material 2015-08-03T04:00:00Z 2015 8     2015-08-03T19:02:40Z   0 0 0900006481bbbbcf
FDA-2013-D-1358-0013 FDA None FDA-2013-D-1358 Reference 14 - Interference Testing in Clinical Chemistry; Approved Guideline (2) re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation Supporting & Related Material Background Material 2015-08-03T04:00:00Z 2015 8     2015-08-03T19:02:53Z   0 0 0900006481bbbbd1
FDA-2013-D-1358-0001 FDA None FDA-2013-D-1358 Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Availability Notice Notice of Availability 2013-11-20T05:00:00Z 2013 11 2013-11-20T05:00:00Z 2014-02-19T04:59:59Z 2015-07-13T17:54:08Z 2013-27774 0 0 090000648148bc0a
FDA-2013-D-1358-0002 FDA None FDA-2013-D-1358 Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation Other Guidance 2013-11-20T05:00:00Z 2013 11 2013-11-20T05:00:00Z   2024-11-12T05:24:15Z   1 0 090000648148c493

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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;