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-2023-D-4395" sorted by posted_date descending

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

posted_year 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2023-D-4395-0034 FDA None FDA-2023-D-4395 Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff Other Guidance 2025-12-18T05:00:00Z 2025 12 2025-12-18T05:00:00Z   2025-12-18T18:40:27Z   1 0 09000064b90ee9f4
FDA-2023-D-4395-0033 FDA None FDA-2023-D-4395 Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2025-12-18T05:00:00Z 2025 12     2025-12-18T18:40:06Z 2025-23252 0 0 09000064b90ee7f9
FDA-2023-D-4395-0003 FDA None FDA-2023-D-4395 Request for Extension from Advanced Medical Technology Association (AdvaMed) Other Request for Extension 2023-12-20T05:00:00Z 2023 12 2023-12-20T05:00:00Z   2023-12-20T22:31:58Z   0 0 090000648634c2a8
FDA-2023-D-4395-0002 FDA None FDA-2023-D-4395 Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff - DRAFT GUIDANCE Other Guidance 2023-12-19T05:00:00Z 2023 12 2023-12-19T05:00:00Z 2024-02-21T04:59:59Z 2025-12-18T18:41:09Z   0 0 0900006486347413
FDA-2023-D-4395-0001 FDA None FDA-2023-D-4395 Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2023-12-19T05:00:00Z 2023 12 2023-12-19T05:00:00Z   2023-12-19T16:31:03Z 2023-27852 0 0 0900006486346c20

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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;