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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

11 rows where docket_id = "FDA-2018-N-0236" and posted_year = 2019 sorted by posted_date descending

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  • 2019 · 11 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2018-N-0236-0010 FDA None FDA-2018-N-0236 06 - Reference 5 - FDA's guidance Collection of Race and Ethnicity Data in Clinical Trials Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:28:59Z   0 0 090000648390d0be
FDA-2018-N-0236-0014 FDA None FDA-2018-N-0236 10 - Reference 9 - Patient Preference Information--Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests . . . Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:32:11Z   0 0 090000648390d0c2
FDA-2018-N-0236-0009 FDA None FDA-2018-N-0236 05 - Reference 4 - FDA's Guidance Collection of Race and Ethnicity Data in Clinical Trials Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:28:19Z   0 0 090000648390d0bd
FDA-2018-N-0236-0013 FDA None FDA-2018-N-0236 09 - Reference 8 - FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-26T20:09:39Z   0 0 090000648390d0c1
FDA-2018-N-0236-0005 FDA None FDA-2018-N-0236 01 - List of References Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:25:30Z   0 0 090000648390cc75
FDA-2018-N-0236-0015 FDA None FDA-2018-N-0236 11 - Reference 10 - Preliminary Analysis of Economic Impacts Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-26T19:59:25Z   0 0 090000648390d0c3
FDA-2018-N-0236-0006 FDA None FDA-2018-N-0236 02 - Reference 1 - De Novo Classification Process (Evaluation of Automatic Class III Designation) - Final Guidance Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-26T19:59:00Z   0 0 090000648390cc76
FDA-2018-N-0236-0012 FDA None FDA-2018-N-0236 08 - Reference 7 - Use of International Standard ISO-10993, Biological evaluation of medical devices--Part 1- Evaluation and testing within a risk management process Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:30:25Z   0 0 090000648390d0c0
FDA-2018-N-0236-0011 FDA None FDA-2018-N-0236 07 - Reference 6 - FDA's guidance Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:29:43Z   0 0 090000648390d0bf
FDA-2018-N-0236-0008 FDA None FDA-2018-N-0236 04 - Reference 3 - FDA's guidance - eCopy Program for Medical Device Submissions Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:27:37Z   0 0 090000648390cc78
FDA-2018-N-0236-0007 FDA None FDA-2018-N-0236 03 - Reference 2 - FDA's guidance "Procedures for Class II Device Exemptions from Premarket Notification" Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-26T19:31:29Z   0 0 090000648390cc77

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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;