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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

11 rows where docket_id = "FDA-2017-D-6535" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-6535-0009 FDA None FDA-2017-D-6535 Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry Other Guidance 2019-03-26T04:00:00Z 2019 3 2019-03-26T04:00:00Z   2024-11-12T22:57:09Z   1 0 0900006483b2f6b1
FDA-2017-D-6535-0016 FDA None FDA-2017-D-6535 Reference 7 - Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices; Guidance for Industry and Food and Drug Administration Staff RE: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry Supporting & Related Material Background Material 2019-03-26T04:00:00Z 2019 3     2019-03-26T15:31:28Z   0 0 0900006483b2fa0f
FDA-2017-D-6535-0013 FDA None FDA-2017-D-6535 Reference 4 - Federal Register Notice International Harmonization; Policy on Standards RE: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry Supporting & Related Material Background Material 2019-03-26T04:00:00Z 2019 3     2019-03-26T15:32:08Z   0 0 0900006483b2f6b6
FDA-2017-D-6535-0008 FDA None FDA-2017-D-6535 Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Guidance for Industry; Availability Notice Notice of Availability 2019-03-26T04:00:00Z 2019 3 2019-03-26T04:00:00Z   2019-03-26T14:09:07Z 2019-05760 0 0 0900006483b2e430
FDA-2017-D-6535-0012 FDA None FDA-2017-D-6535 Reference 3 - FDA Staff Manual Guides, Volume IV - Agency Program Directives, Common Standards, Developmant and Use of Standards, SMG 9100.1 RE: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry Supporting & Related Material Background Material 2019-03-26T04:00:00Z 2019 3     2019-03-26T15:33:06Z   0 0 0900006483b2f6b5
FDA-2017-D-6535-0014 FDA None FDA-2017-D-6535 Reference 5 - Guidance for Industry Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage RE: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry Supporting & Related Material Background Material 2019-03-26T04:00:00Z 2019 3     2019-03-26T15:31:06Z   0 0 0900006483b2fa0d
FDA-2017-D-6535-0015 FDA None FDA-2017-D-6535 Reference 6 - Providing Regulatory Submissions in Electronic Format - Standardized Study Data; Guidance for Industry RE: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry Supporting & Related Material Background Material 2019-03-26T04:00:00Z 2019 3     2019-03-26T15:31:16Z   0 0 0900006483b2fa0e
FDA-2017-D-6535-0011 FDA None FDA-2017-D-6535 Reference 2 - National Technology Tranfer and Advancement Act of 1995 RE: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry Supporting & Related Material Background Material 2019-03-26T04:00:00Z 2019 3     2019-03-26T15:33:50Z   0 0 0900006483b2f6b4
FDA-2017-D-6535-0010 FDA None FDA-2017-D-6535 Reference 1 - OMB Circular A-119 Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities re: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry Supporting & Related Material Background Material 2019-03-26T04:00:00Z 2019 3     2019-03-26T15:27:08Z   0 0 0900006483b2f6b3
FDA-2017-D-6535-0002 FDA None FDA-2017-D-6535 Draft Guidance for Industry on Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Other Guidance 2017-12-19T05:00:00Z 2017 12 2017-12-19T05:00:00Z   2024-11-07T01:16:23Z   1 0 0900006482d3bf1b
FDA-2017-D-6535-0001 FDA None FDA-2017-D-6535 Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2017-12-19T05:00:00Z 2017 12 2017-12-19T05:00:00Z 2018-03-20T03:59:59Z 2018-03-20T01:03:43Z 2017-27275 0 0 0900006482d3ac76

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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;