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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

12 rows where docket_id = "FDA-2021-N-0309" sorted by posted_date descending

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

document_type 3

  • Supporting & Related Material 10
  • Proposed Rule 1
  • Rule 1

posted_year 2

  • 2021 11
  • 2023 1

agency_id 1

  • FDA 12
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2021-N-0309-0017 FDA None FDA-2021-N-0309 Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedure Rule Advance Notice of Proposed Rulemaking (ANPRM) 2023-03-30T04:00:00Z 2023 3 2023-03-30T04:00:00Z   2023-03-30T17:12:14Z 2023-06565 0 0 0900006485892ecc
FDA-2021-N-0309-0009 FDA None FDA-2021-N-0309 Reference 1 - G - Dec 12 2013 - Questions for Panel Supporting & Related Material Background Material 2021-12-20T05:00:00Z 2021 12     2021-12-20T15:12:22Z   0 0 0900006484ed6925
FDA-2021-N-0309-0011 FDA None FDA-2021-N-0309 Reference 2 - Failure_of_the_Fernstrom_ball_in_contemporary.20 Supporting & Related Material Background Material 2021-12-20T05:00:00Z 2021 12     2021-12-20T15:13:10Z   0 0 0900006484ed6927
FDA-2021-N-0309-0008 FDA None FDA-2021-N-0309 Reference 1 - F - FDA Spinal Spheres Panel Questions Supporting & Related Material Background Material 2021-12-20T05:00:00Z 2021 12     2021-12-20T15:12:09Z   0 0 0900006484ed6924
FDA-2021-N-0309-0010 FDA None FDA-2021-N-0309 Reference 1 - H - FDA Spinal Spheres Presentation Supporting & Related Material Background Material 2021-12-20T05:00:00Z 2021 12     2021-12-20T15:12:34Z   0 0 0900006484ed6926
FDA-2021-N-0309-0004 FDA None FDA-2021-N-0309 Reference 1 - B - Executive Summary - Spinal Spheres PANEL Supporting & Related Material Background Material 2021-12-20T05:00:00Z 2021 12     2021-12-20T15:11:14Z   0 0 0900006484ed6920
FDA-2021-N-0309-0007 FDA None FDA-2021-N-0309 Reference 1 - E - Master Slide Device Classification Panel - revised for 2013.12.12 meeting Supporting & Related Material Background Material 2021-12-20T05:00:00Z 2021 12     2021-12-20T15:11:54Z   0 0 0900006484ed6923
FDA-2021-N-0309-0003 FDA None FDA-2021-N-0309 Reference 1 - A - 24 hr OR 121213 Supporting & Related Material Background Material 2021-12-20T05:00:00Z 2021 12     2021-12-20T15:11:03Z   0 0 0900006484ed691f
FDA-2021-N-0309-0002 FDA None FDA-2021-N-0309 List of References for Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for use in Intervertebraral Fusion Supporting & Related Material Background Material 2021-12-20T05:00:00Z 2021 12     2021-12-20T15:10:42Z   0 0 0900006484ed6801
FDA-2021-N-0309-0006 FDA None FDA-2021-N-0309 Reference 1 - D - Spinal Spheres Devices Roster Supporting & Related Material Background Material 2021-12-20T05:00:00Z 2021 12     2021-12-20T15:11:40Z   0 0 0900006484ed6922
FDA-2021-N-0309-0005 FDA None FDA-2021-N-0309 Reference 1 - C - Transcript Orthopaedic and Rehabilitation Devices Panel of 12-12-13 Supporting & Related Material Background Material 2021-12-20T05:00:00Z 2021 12     2021-12-20T15:11:27Z   0 0 0900006484ed6921
FDA-2021-N-0309-0001 FDA None FDA-2021-N-0309 Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedures Proposed Rule Amendment 2021-12-15T05:00:00Z 2021 12 2021-12-15T05:00:00Z 2022-03-16T03:59:59Z 2022-03-16T01:00:43Z 2021-27139 0 0 0900006484ecae96

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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;
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