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

5 rows where docket_id = "FDA-2016-D-2565" and posted_year = 2016 sorted by posted_date descending

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

posted_year 1

  • 2016 · 5 ✖

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2016-D-2565-0001 FDA None FDA-2016-D-2565 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability Notice Notice of Availability 2016-09-12T04:00:00Z 2016 9 2016-09-12T04:00:00Z 2016-11-15T04:59:59Z 2016-11-15T02:00:50Z 2016-21876 0 0 09000064821f8301
FDA-2016-D-2565-0002 FDA None FDA-2016-D-2565 Reference 1 - List of References for Third Party Review Program Draft Guidance re 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability Supporting & Related Material Background Material 2016-09-12T04:00:00Z 2016 9     2016-09-12T13:37:15Z   0 0 09000064821df168
FDA-2016-D-2565-0005 FDA None FDA-2016-D-2565 Draft Guidance for Industry Food and Drug Administration Staff on 510(k) Third Party Review Program Other Guidance 2016-09-12T04:00:00Z 2016 9 2016-09-12T04:00:00Z   2024-11-07T23:49:36Z   1 0 09000064821f9e4c
FDA-2016-D-2565-0003 FDA None FDA-2016-D-2565 Reference 2 - International Medical Device Regulators Forum’s Medical Device Single Audit Program documents re 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability Supporting & Related Material Background Material 2016-09-12T04:00:00Z 2016 9     2016-09-12T13:37:25Z   0 0 09000064821df16c
FDA-2016-D-2565-0004 FDA None FDA-2016-D-2565 Reference 3 - FDA Draft Guidance entitled Accreditation and Reaccreditation Process for Firms under the Third Party Review Program Part I_ 2013 re 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability Supporting & Related Material Background Material 2016-09-12T04:00:00Z 2016 9     2016-09-12T13:37:35Z   0 0 09000064821df16e

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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;