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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-5570" sorted by posted_date descending

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Suggested facets: 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-5570-0020 FDA None FDA-2017-D-5570 Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff Other Guidance 2020-02-26T05:00:00Z 2020 2 2020-02-26T05:00:00Z   2024-11-06T23:33:16Z   1 0 09000064843b60b4
FDA-2017-D-5570-0019 FDA None FDA-2017-D-5570 Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2020-02-26T05:00:00Z 2020 2 2020-02-26T05:00:00Z   2020-02-26T14:53:23Z 2020-03860 0 0 09000064843b4ec1
FDA-2017-D-5570-0012 FDA None FDA-2017-D-5570 Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2018-11-29T05:00:00Z 2018 11 2018-11-29T05:00:00Z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 2018-25959 1 0 090000648390c0fa
FDA-2017-D-5570-0013 FDA None FDA-2017-D-5570 Draft Guidance for Industry and FDA_Select Updates for CLIA of 1988 Waiver Applications for Manufacturers of IVD Devices_11-29-2018 Other Guidance 2018-11-29T05:00:00Z 2018 11 2018-11-29T05:00:00Z 2019-02-28T04:59:59Z 2024-11-12T22:50:08Z   1 0 090000648390cc70
FDA-2017-D-5570-0006 FDA None FDA-2017-D-5570 Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; 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 2018-03-31T01:01:21Z 2018-01349 0 0 0900006482e6be59
FDA-2017-D-5570-0005 FDA None FDA-2017-D-5570 Request for Extension from Coalition for CLIA Waiver Reform (Epstein Becker & Green, P.C.) Other Request for Extension 2018-01-08T05:00:00Z 2018 1 2018-01-08T05:00:00Z   2018-01-08T16:20:10Z   0 0 0900006482d9d48d
FDA-2017-D-5570-0001 FDA None FDA-2017-D-5570 Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; 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 2018-01-14T03:27:08Z 2017-25775 0 0 0900006482cbbc77
FDA-2017-D-5570-0002 FDA None FDA-2017-D-5570 Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices Draft Guidance for Industry and Food and Drug Administration Staff Other Guidance 2017-11-29T05:00:00Z 2017 11 2017-11-29T05:00:00Z 2018-03-31T03:59:59Z 2024-11-07T01:12:28Z   1 0 0900006482cbce4e

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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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