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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

15 rows where docket_id = "FDA-2016-N-2491" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2491-0024 FDA None FDA-2016-N-2491 Withdrawal of the Laser Products; Proposed Amendment to Performance Standard and the Electronic Submission of Labeling for Certain Home-Use Medical Devices Proposed Rule Withdrawal 2018-11-01T04:00:00Z 2018 11 2018-11-01T04:00:00Z   2018-11-01T14:37:41Z 2018-23916 0 0 090000648387ac10
FDA-2016-N-2491-0003 FDA None FDA-2016-N-2491 Reference 2 - Medical Device Home Use Initiative re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule Supporting & Related Material Background Material 2016-10-18T04:00:00Z 2016 10     2016-10-18T14:08:29Z   0 0 090000648230fb58
FDA-2016-N-2491-0011 FDA None FDA-2016-N-2491 Reference 10 - Medical Device Labeling for Health Care Practitioners Focus Group Study FINAL May 2011 re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule Supporting & Related Material Background Material 2016-10-18T04:00:00Z 2016 10     2016-10-18T14:17:08Z   0 0 090000648230fdb3
FDA-2016-N-2491-0012 FDA None FDA-2016-N-2491 Reference 11 - Device Labeling Study- Practitioner Perspectives on Utility Format and Content - Report Summary re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule Supporting & Related Material Background Material 2016-10-18T04:00:00Z 2016 10     2016-10-18T14:17:37Z   0 0 090000648230fdc3
FDA-2016-N-2491-0008 FDA None FDA-2016-N-2491 Reference 7 - CDRH Preliminary Internal Evaluations Vol I 510(k) Report re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule Supporting & Related Material Background Material 2016-10-18T04:00:00Z 2016 10     2016-10-18T14:14:28Z   0 0 090000648230fdac
FDA-2016-N-2491-0013 FDA None FDA-2016-N-2491 Reference 12 - Public Workshop-Medical Device Labeling September 29-30 2015 re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule Supporting & Related Material Background Material 2016-10-18T04:00:00Z 2016 10     2016-10-18T14:18:24Z   0 0 090000648230fdc4
FDA-2016-N-2491-0014 FDA None FDA-2016-N-2491 Reference 13 - PRIA Initial Regulatory Flexibility Analysis and Unfunded Mandates Reform Act Analysis re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule Supporting & Related Material Background Material 2016-10-18T04:00:00Z 2016 10     2016-10-18T14:19:01Z   0 0 090000648230fdc5
FDA-2016-N-2491-0005 FDA None FDA-2016-N-2491 Reference 4 - Medical Instrumentation--Accessibility and Usability Considerations -Winters and Story re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule Supporting & Related Material Background Material 2016-10-18T04:00:00Z 2016 10     2016-10-18T14:10:18Z   0 0 090000648230fb5a
FDA-2016-N-2491-0002 FDA None FDA-2016-N-2491 Reference 1 - List of References re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule Supporting & Related Material Background Material 2016-10-18T04:00:00Z 2016 10     2016-10-18T14:06:01Z   0 0 0900006482304153
FDA-2016-N-2491-0004 FDA None FDA-2016-N-2491 Reference 3 - Guidance on Medical Device Patient Labeling re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule Supporting & Related Material Background Material 2016-10-18T04:00:00Z 2016 10     2016-10-18T14:09:09Z   0 0 090000648230fb59
FDA-2016-N-2491-0007 FDA None FDA-2016-N-2491 Reference 6 - CDRH Preliminary Internal Evaluations Vol II Task Force Report - FINAL re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule Supporting & Related Material Background Material 2016-10-18T04:00:00Z 2016 10     2016-10-18T14:13:56Z   0 0 090000648230fdab
FDA-2016-N-2491-0009 FDA None FDA-2016-N-2491 Reference 8 - 510(k) and Science Report Recommendations - Comments Summary re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule Supporting & Related Material Background Material 2016-10-18T04:00:00Z 2016 10     2016-10-18T14:14:59Z   0 0 090000648230fdad
FDA-2016-N-2491-0010 FDA None FDA-2016-N-2491 Reference 9 - Transcript of April 7 2011 Public Meeting on Medical Device Use in the Home Environment Workshop re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule Supporting & Related Material Background Material 2016-10-18T04:00:00Z 2016 10     2016-10-18T14:15:39Z   0 0 090000648230fdae
FDA-2016-N-2491-0006 FDA None FDA-2016-N-2491 Reference 5 - Basic Statistics About Home Care NAHC 2010 re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule Supporting & Related Material Background Material 2016-10-18T04:00:00Z 2016 10     2016-10-18T14:10:46Z   0 0 090000648230fdaa
FDA-2016-N-2491-0001 FDA None FDA-2016-N-2491 Electronic Submission of Labeling for Certain Home-Use Medical Devices Proposed Rule Notice of Proposed Rulemaking (NPRM) 2016-10-17T04:00:00Z 2016 10 2016-10-17T04:00:00Z 2017-01-18T04:59:59Z 2017-01-18T02:01:20Z 2016-25026 0 0 0900006482303611

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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;