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

8 rows where docket_id = "FDA-2016-P-0159" 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)

posted_year 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-P-0159-0008 FDA None FDA-2016-P-0159 Reference 1 - Guidance - Procedures for Class II Device Exemptions from Premarket Notification 1998 Supporting & Related Material Guidance 2016-10-04T04:00:00Z 2016 10     2016-10-04T16:55:57Z   0 0 0900006482295b64
FDA-2016-P-0159-0007 FDA None FDA-2016-P-0159 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   2016-10-04T15:42:52Z 2016-23901 0 0 09000064822912df
FDA-2016-P-0159-0006 FDA None FDA-2016-P-0159 Denial letter from the FDA CDRH to Biorex Labs LLC Other Denial of Petition 2016-07-12T04:00:00Z 2016 7 2016-07-12T04:00:00Z   2016-07-12T17:23:39Z   0 0 09000064820a44c0
FDA-2016-P-0159-0005 FDA None FDA-2016-P-0159 Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format Notice Announcement 2016-05-04T04:00:00Z 2016 5 2016-05-04T04:00:00Z 2016-06-04T03:59:59Z 2016-05-04T14:42:25Z 2016-10388 0 0 0900006481fa8786
FDA-2016-P-0159-0003 FDA None FDA-2016-P-0159 Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format Notice Request for Comments 2016-03-24T04:00:00Z 2016 3 2016-03-24T04:00:00Z 2016-04-26T03:59:59Z 2016-03-24T13:55:03Z 2016-06709 0 0 0900006481edc6ef
FDA-2016-P-0159-0004 FDA None FDA-2016-P-0159 Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff re Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format Supporting & Related Material Background Material 2016-03-24T04:00:00Z 2016 3     2016-03-28T19:32:37Z   0 0 0900006481edd298
FDA-2016-P-0159-0001 FDA None FDA-2016-P-0159 Citizen Petition from Biorex Labs LLC Other Citizen Petition 2016-01-19T05:00:00Z 2016 1 2016-01-19T05:00:00Z   2024-11-11T21:22:37Z   1 0 0900006481e0efaf
FDA-2016-P-0159-0002 FDA None FDA-2016-P-0159 Acknowledgement Letter from FDA DDM to Biorex Labs LLC Other Acknowledgement Letter/Receipt 2016-01-19T05:00:00Z 2016 1 2016-01-19T05:00:00Z   2016-01-19T21:40:02Z   0 0 0900006481e10188

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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;