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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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15 rows where docket_id = "FDA-2017-N-6730" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-N-6730-0041 FDA None FDA-2017-N-6730 Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers Rule Final Rule 2024-08-29T04:00:00Z 2024 8     2024-08-29T13:19:24Z 2024-19414 0 0 09000064866b35bb
FDA-2017-N-6730-0038 FDA None FDA-2017-N-6730 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2021-10-04T04:00:00Z 2021 10 2021-10-04T04:00:00Z   2021-10-04T22:08:16Z 2021-21386 0 0 0900006484db6ed9
FDA-2017-N-6730-0037 FDA None FDA-2017-N-6730 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting Notice 30 Day Proposed Information Collection 2021-07-28T04:00:00Z 2021 7 2021-07-28T04:00:00Z 2021-08-28T03:59:59Z 2021-07-28T14:21:18Z 2021-16034 0 0 0900006484c14958
FDA-2017-N-6730-0036 FDA None FDA-2017-N-6730 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting Notice 60 Day Proposed Information Collection 2021-04-29T04:00:00Z 2021 4 2021-04-29T04:00:00Z 2021-06-29T03:59:59Z 2021-05-03T21:35:23Z 2021-08962 0 0 0900006484abc2e8
FDA-2017-N-6730-0035 FDA None FDA-2017-N-6730 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2018-09-28T04:00:00Z 2018 9 2018-09-28T04:00:00Z   2018-10-23T15:15:20Z 2018-21209 0 0 09000064837801da
FDA-2017-N-6730-0034 FDA None FDA-2017-N-6730 Medical Devices and Device-Led Combination Products: Voluntary Malfunction Summary Reporting Program for Manufacturers Rule Final Rule 2018-08-17T04:00:00Z 2018 8 2018-08-17T04:00:00Z   2024-08-29T18:23:06Z 2018-17770 0 0 090000648363074e
FDA-2017-N-6730-0033 FDA None FDA-2017-N-6730 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Malfunction Summary Reporting Program for Manufacturers Notice 30 Day Proposed Information Collection 2018-06-08T04:00:00Z 2018 6 2018-06-08T04:00:00Z 2018-07-10T03:59:59Z 2018-06-10T01:03:01Z 2018-12336 0 0 0900006483398b52
FDA-2017-N-6730-0007 FDA None FDA-2017-N-6730 Ref. 1, FDA, Medical Device Reporting--Alternative Summary Reporting (ASR) Program Guidance for Industry Supporting & Related Material Background Material 2017-12-26T05:00:00Z 2017 12     2017-12-26T17:58:17Z   0 0 0900006482d737cd
FDA-2017-N-6730-0004 FDA None FDA-2017-N-6730 Ref. 4, MDUFA IV Performance Goals and Procedures. Fiscal Years 2019 through 2022 Commitment Letter Supporting & Related Material Background Material 2017-12-26T05:00:00Z 2017 12     2017-12-26T17:58:17Z   0 0 0900006482d737d0
FDA-2017-N-6730-0002 FDA None FDA-2017-N-6730 Ref. 6, Food and Drug Administration, Electronic Medical Device Reporting Supporting & Related Material Background Material 2017-12-26T05:00:00Z 2017 12     2017-12-26T17:58:16Z   0 0 0900006482d73945
FDA-2017-N-6730-0008 FDA None FDA-2017-N-6730 List of References - Voluntary Malfunction Summary Reporting Program fro Manufacturers Supporting & Related Material Background Material 2017-12-26T05:00:00Z 2017 12     2017-12-26T17:58:17Z   0 0 0900006482d737cb
FDA-2017-N-6730-0005 FDA None FDA-2017-N-6730 Ref. 3, FDA Form 3500A - MEDWATCH Supporting & Related Material Background Material 2017-12-26T05:00:00Z 2017 12     2017-12-26T17:58:17Z   0 0 0900006482d737cf
FDA-2017-N-6730-0003 FDA None FDA-2017-N-6730 Ref. 5, Appedix A, Case Examples of Summary Malfunction Reporting Supporting & Related Material Background Material 2017-12-26T05:00:00Z 2017 12     2017-12-26T17:58:17Z   0 0 0900006482d737d1
FDA-2017-N-6730-0006 FDA None FDA-2017-N-6730 Ref. 2, Food and Drug Administration, MDR Adverse Event Codes Supporting & Related Material Background Material 2017-12-26T05:00:00Z 2017 12     2017-12-26T17:58:17Z   0 0 0900006482d737ce
FDA-2017-N-6730-0001 FDA None FDA-2017-N-6730 Center for Devices and Radiological Health; Medical Devices and Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers Proposed Rule Notice of Proposed Rulemaking (NPRM) 2017-12-26T05:00:00Z 2017 12 2017-12-26T05:00:00Z 2018-02-27T04:59:59Z 2024-08-29T18:24:28Z 2017-27650 0 0 0900006482d7293c

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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;