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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

7 rows where docket_id = "FDA-2016-P-1026" sorted by posted_date descending

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

document_type 4

  • Other 3
  • Supporting & Related Material 2
  • Notice 1
  • Rule 1

posted_year 1

  • 2016 7

agency_id 1

  • FDA 7
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-P-1026-0006 FDA None FDA-2016-P-1026 Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format Rule Final Rule 2016-10-04T04:00:00Z 2016 10 2016-10-04T04:00:00Z   2016-10-04T16:10:04Z 2016-23899 0 0 0900006482291406
FDA-2016-P-1026-0007 FDA None FDA-2016-P-1026 Reference 1 - Guidance - Procedures for Class II Device Exemptions from Premarket Notification 1998 Supporting & Related Material Guidance 2016-10-04T04:00:00Z 2016 10     2016-10-04T16:53:15Z   0 0 0900006482295b63
FDA-2016-P-1026-0005 FDA None FDA-2016-P-1026 Letter from CDRH to Germaine Laboratories Inc Other Denial 2016-09-12T04:00:00Z 2016 9 2016-09-12T04:00:00Z   2016-09-12T16:09:54Z   0 0 09000064821fad0d
FDA-2016-P-1026-0003 FDA None FDA-2016-P-1026 Medical Devices; Exemption from Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format; Republication Notice Notice of Publication 2016-06-20T04:00:00Z 2016 6 2016-06-20T04:00:00Z 2016-07-21T03:59:59Z 2016-06-20T12:09:47Z 2016-14459 0 0 090000648204fcd6
FDA-2016-P-1026-0004 FDA None FDA-2016-P-1026 Reference 1 - Guidance for Industry and CDRH Staff on Procedures for Class II Device Exemptions from Premarket Notification Supporting & Related Material Background Material 2016-06-20T04:00:00Z 2016 6     2024-11-07T23:47:40Z   0 0 090000648204943e
FDA-2016-P-1026-0002 FDA None FDA-2016-P-1026 Acknowledgement Letter from FDA DDM to Germaine Laboratories, Inc. Other Acknowledgement Letter/Receipt 2016-03-23T04:00:00Z 2016 3 2016-03-23T04:00:00Z   2016-03-23T13:02:51Z   0 0 0900006481ed6723
FDA-2016-P-1026-0001 FDA None FDA-2016-P-1026 Citizen Petition from Germaine Laboratories, Inc. Other Citizen Petition 2016-03-23T04:00:00Z 2016 3 2016-03-23T04:00:00Z   2024-11-12T06:05:46Z   1 0 0900006481ed61cd

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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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