documents

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

7 rows where docket_id = "FDA-2011-D-0790" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, comment_end_date, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 3

document_type 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-D-0790-0036 FDA None FDA-2011-D-0790 Guidance for Sponsors Clinical Investigators Institutional Review Boards and Food and Drug Administration Staff Other Guidance 2014-08-19T04:00:00Z 2014 8 2014-08-19T04:00:00Z   2024-11-11T20:54:11Z   1 0 0900006481830756
FDA-2011-D-0790-0035 FDA None FDA-2011-D-0790 Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Availability Notice Notice of Availability 2014-08-19T04:00:00Z 2014 8 2014-08-19T04:00:00Z   2014-08-19T14:35:26Z 2014-19577 0 0 090000648182f7fb
FDA-2011-D-0790-0019 FDA None FDA-2011-D-0790 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff Other Guidance 2013-06-14T04:00:00Z 2013 6 2013-06-14T04:00:00Z   2024-11-12T05:17:10Z   1 0 0900006481320322
FDA-2011-D-0790-0018 FDA None FDA-2011-D-0790 Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2013-06-14T04:00:00Z 2013 6 2013-06-14T04:00:00Z 2013-09-13T03:59:59Z 2013-09-21T01:01:47Z 2013-14137 0 0 090000648131ff08
FDA-2011-D-0790-0004 FDA None FDA-2011-D-0790 Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Staff; Availability: Decisions for Investigational Device Exemption Clinical Investigations Notice Notice of Extension 2011-12-27T05:00:00Z 2011 12 2011-12-27T05:00:00Z 2012-03-10T04:59:59Z 2011-12-27T17:03:18Z 2011-33141 0 0 0900006480f89877
FDA-2011-D-0790-0001 FDA None FDA-2011-D-0790 Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Staff; Availability: Decisions for Investigational Device Exemption Clinical Investigations Notice Notice of Availability 2011-11-10T05:00:00Z 2011 11 2011-11-10T05:00:00Z 2012-02-09T04:59:59Z 2011-11-10T14:10:31Z 2011-29118 0 0 0900006480f69c13
FDA-2011-D-0790-0002 FDA None FDA-2011-D-0790 Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff, FDA Decisions for Investigational Device Exemption Clinical Investigations Other Guidance 2011-11-10T05:00:00Z 2011 11 2011-11-10T05:00:00Z 2012-02-09T04:59:59Z 2011-11-10T14:18:11Z   0 0 0900006480f69b65

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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;