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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

8 rows where docket_id = "FDA-2017-D-5625" sorted by posted_date descending

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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 3

  • 2018 4
  • 2017 2
  • 2020 2

document_type 2

  • Notice 4
  • Other 4

agency_id 1

  • FDA 8
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2017-D-5625-0015 FDA None FDA-2017-D-5625 Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Data Availability 2020-02-26T05:00:00Z 2020 2 2020-02-26T05:00:00Z   2020-02-26T15:03:25Z 2020-03859 0 0 09000064843b4ec8
FDA-2017-D-5625-0016 FDA None FDA-2017-D-5625 Recommendations for Dual 510(k) and CLIA Waiver by Application Studies Guidance for Industry and Food and Drug Administration Staff Other Guidance 2020-02-26T05:00:00Z 2020 2 2020-02-26T05:00:00Z   2024-11-06T23:33:00Z   1 0 09000064843b6329
FDA-2017-D-5625-0012 FDA None FDA-2017-D-5625 Draft Guidance for Industry and FDA_name_Recommendations for Dual 510(k) and CLIA Wavier by Application Studies_11-29-2018 Other Guidance 2018-11-29T05:00:00Z 2018 11 2018-11-29T05:00:00Z 2019-02-28T04:59:59Z 2024-11-12T22:50:42Z   1 0 090000648390cf30
FDA-2017-D-5625-0011 FDA None FDA-2017-D-5625 Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2018-11-29T05:00:00Z 2018 11 2018-11-29T05:00:00Z 2019-02-28T04:59:59Z 2024-11-12T22:50:46Z 2018-25960 1 0 090000648390c0b9
FDA-2017-D-5625-0005 FDA None FDA-2017-D-5625 Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period Notice Notice of Availability 2018-01-26T05:00:00Z 2018 1 2018-01-26T05:00:00Z 2018-03-31T03:59:59Z 2018-03-31T01:00:39Z 2018-01350 0 0 0900006482e6c0cd
FDA-2017-D-5625-0004 FDA None FDA-2017-D-5625 Request for Extension from Coalition for CLIA Waiver Reform (Epstein Becker & Green, P.C.) Other Electronic Regulation from Form 2018-01-08T05:00:00Z 2018 1 2018-01-08T05:00:00Z   2018-01-08T16:23:20Z   0 0 0900006482d9db46
FDA-2017-D-5625-0002 FDA None FDA-2017-D-5625 Recommendations for Dual 510(k) and CLIA Waiver by Application Studies Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE Other Guidance 2017-11-29T05:00:00Z 2017 11 2017-11-29T05:00:00Z 2018-03-31T03:59:59Z 2024-11-07T01:12:24Z   1 0 0900006482cbce95
FDA-2017-D-5625-0001 FDA None FDA-2017-D-5625 Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2017-11-29T05:00:00Z 2017 11 2017-11-29T05:00:00Z 2018-01-30T04:59:59Z 2018-01-14T03:27:10Z 2017-25774 0 0 0900006482cbbd24

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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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