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

18 rows where docket_id = "FDA-2016-D-2565" sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

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 7

document_type 3

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2565-0036 FDA None FDA-2016-D-2565 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations Other Guidance 2024-11-21T05:00:00Z 2024 11 2024-11-21T05:00:00Z   2024-11-21T14:12:37Z   1 0 090000648682bfa0
FDA-2016-D-2565-0035 FDA None FDA-2016-D-2565 510(k) Third Party Review Program and Third Party Emergency Use Authorization Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability Notice Notice of Availability 2024-11-21T05:00:00Z 2024 11     2024-11-21T14:14:28Z 2024-27085 0 0 090000648682c244
FDA-2016-D-2565-0030 FDA None FDA-2016-D-2565 Draft Guidance for Industry and FDA_510(k) Third Party Review Program and Third Party EUA Reivew Other Guidance 2023-12-22T05:00:00Z 2023 12 2023-12-22T05:00:00Z 2024-02-21T04:59:59Z 2024-11-21T14:13:13Z   0 0 090000648634e6c9
FDA-2016-D-2565-0029 FDA None FDA-2016-D-2565 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability Notice Notice of Availability 2023-12-21T05:00:00Z 2023 12     2023-12-21T17:23:07Z 2023-28095 0 0 090000648634e286
FDA-2016-D-2565-0028 FDA None FDA-2016-D-2565 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2023-02-14T05:00:00Z 2023 2 2023-02-14T05:00:00Z   2023-02-14T14:49:38Z 2023-03073 0 0 0900006485693529
FDA-2016-D-2565-0027 FDA None FDA-2016-D-2565 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review Program Notice 30 Day Proposed Information Collection 2022-10-27T04:00:00Z 2022 10 2022-10-27T04:00:00Z 2022-11-29T04:59:59Z 2022-10-27T14:32:02Z 2022-23377 0 0 09000064854627b2
FDA-2016-D-2565-0022 FDA None FDA-2016-D-2565 Agency Information Collection Activities; Proposed Collection; Comment Request; 510(k) Third-Party Review Program Notice 60 Day Proposed Information Collection 2022-06-24T04:00:00Z 2022 6 2022-06-24T04:00:00Z 2022-08-24T03:59:59Z 2022-10-06T18:45:23Z 2022-13521 0 0 090000648518c24c
FDA-2016-D-2565-0019 FDA None FDA-2016-D-2565 The 510(k) Third Party Review Program; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability Notice Notice of Availability 2020-03-12T04:00:00Z 2020 3 2020-03-12T04:00:00Z   2020-03-12T13:19:53Z 2020-05080 0 0 090000648443d205
FDA-2016-D-2565-0020 FDA None FDA-2016-D-2565 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations Other Guidance 2020-03-12T04:00:00Z 2020 3 2020-03-12T04:00:00Z   2024-11-12T23:18:21Z   1 0 090000648443d91b
FDA-2016-D-2565-0018 FDA None FDA-2016-D-2565 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2019-12-31T05:00:00Z 2019 12 2019-12-31T05:00:00Z   2019-12-31T14:56:03Z 2019-28249 0 0 090000648425d8ae
FDA-2016-D-2565-0017 FDA None FDA-2016-D-2565 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review Program Notice 30 Day Proposed Information Collection 2019-10-15T04:00:00Z 2019 10 2019-10-15T04:00:00Z 2019-11-15T04:59:59Z 2019-10-31T14:53:33Z 2019-22345 0 0 090000648408dee4
FDA-2016-D-2565-0011 FDA None FDA-2016-D-2565 Draft Guidance for Industry-510(k) Third Party Review Program Other Guidance 2018-09-14T04:00:00Z 2018 9 2018-09-14T04:00:00Z 2018-12-14T04:59:59Z 2024-11-07T01:38:07Z   1 0 09000064836ef965
FDA-2016-D-2565-0010 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 2018-09-14T04:00:00Z 2018 9 2018-09-14T04:00:00Z 2018-12-14T04:59:59Z 2018-12-14T02:04:21Z 2018-19992 0 0 09000064836ee543
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

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options: 

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;