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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

14 rows where docket_id = "FDA-2016-N-0406" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-N-0406-0018 FDA None FDA-2016-N-0406 Reference 3 - FDA Executive Summary Blood Products Advisory Committee Meeting - December 3 2014 Supporting & Related Material Background Material 2018-05-18T04:00:00Z 2018 5     2018-05-18T16:37:43Z   0 0 090000648326b5ce
FDA-2016-N-0406-0015 FDA None FDA-2016-N-0406 Reference 6 - Deciding When to Submit a 510k for a Software Change to an Existing Device Guidance for Industry Supporting & Related Material Background Material 2018-05-18T04:00:00Z 2018 5     2018-05-18T16:37:40Z   0 0 090000648326b5d1
FDA-2016-N-0406-0016 FDA None FDA-2016-N-0406 Reference 5 - Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Supporting & Related Material Background Material 2018-05-18T04:00:00Z 2018 5     2018-05-18T16:37:42Z   0 0 090000648326b5d0
FDA-2016-N-0406-0020 FDA None FDA-2016-N-0406 Reference 1 - Blood Products Advisory Committee Meeting transcript-March 20 1998 Supporting & Related Material Background Material 2018-05-18T04:00:00Z 2018 5     2018-05-18T16:37:44Z   0 0 090000648326b5cc
FDA-2016-N-0406-0014 FDA None FDA-2016-N-0406 Medical Devices: Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories Rule Final Rule 2018-05-18T04:00:00Z 2018 5 2018-05-18T04:00:00Z   2018-05-18T14:29:12Z 2018-10610 0 0 090000648327d5df
FDA-2016-N-0406-0019 FDA None FDA-2016-N-0406 Reference 2 - Blood Products Advisory Committee Meeting transcript - December 3 2014 Supporting & Related Material Background Material 2018-05-18T04:00:00Z 2018 5     2018-05-18T16:37:43Z   0 0 090000648326b5cd
FDA-2016-N-0406-0017 FDA None FDA-2016-N-0406 Reference 4 - General Principles of Software Validation Final Guidance for Industry and FDA Staff Supporting & Related Material Background Material 2018-05-18T04:00:00Z 2018 5     2018-05-18T16:37:42Z   0 0 090000648326b5cf
FDA-2016-N-0406-0021 FDA None FDA-2016-N-0406 List of References Final Rule Supporting & Related Material Background Material 2018-05-18T04:00:00Z 2018 5     2018-05-18T16:37:45Z   0 0 090000648326b5cb
FDA-2016-N-0406-0005 FDA None FDA-2016-N-0406 Reference 3 - FDA Executive Summary Blood Products Advisory Committee Meeting - December 3 2014 re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories Supporting & Related Material Background Material 2016-03-01T05:00:00Z 2016 3     2016-03-03T17:11:00Z   0 0 0900006481e9506d
FDA-2016-N-0406-0006 FDA None FDA-2016-N-0406 Reference 4 - Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories Supporting & Related Material Background Material 2016-03-01T05:00:00Z 2016 3     2016-03-03T17:13:53Z   0 0 0900006481e9506e
FDA-2016-N-0406-0001 FDA None FDA-2016-N-0406 Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories Proposed Rule Notice of Proposed Rulemaking (NPRM) 2016-03-01T05:00:00Z 2016 3 2016-03-01T05:00:00Z 2016-06-01T03:59:59Z 2016-06-01T01:00:19Z 2016-04411 0 0 0900006481e951c9
FDA-2016-N-0406-0003 FDA None FDA-2016-N-0406 Reference 1 - Blood Product Advisory Committee Meeting Transcript - March 20, 1998 re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories Supporting & Related Material Background Material 2016-03-01T05:00:00Z 2016 3     2016-03-03T17:11:39Z   0 0 0900006481e9506b
FDA-2016-N-0406-0002 FDA None FDA-2016-N-0406 List of References re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories Supporting & Related Material Background Material 2016-03-01T05:00:00Z 2016 3     2016-03-03T17:09:03Z   0 0 0900006481e95054
FDA-2016-N-0406-0004 FDA None FDA-2016-N-0406 Reference 2 - Blood Product Advisory Committee Meeting transcript - December 3, 2014 re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories Supporting & Related Material Background Material 2016-03-01T05:00:00Z 2016 3     2016-03-03T17:11:21Z   0 0 0900006481e9506c

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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;