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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

10 rows where docket_id = "FDA-2016-N-0436" sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, last_modified, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 2

  • Supporting & Related Material 8
  • Proposed Rule 2

posted_year 1

  • 2016 10

agency_id 1

  • FDA 10
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-N-0436-0115 FDA None FDA-2016-N-0436 Attachment 1 Letter from Zoll to WakeMed Raleigh Hospital re: Comment from Dallas Sutton Supporting & Related Material Background Material 2016-06-02T04:00:00Z 2016 6     2016-06-02T18:29:15Z   0 0 090000648200aa80
FDA-2016-N-0436-0097 FDA None FDA-2016-N-0436 Attachment 1: Sample FDA Docket re: Comment from Acertara Acoustic Laboratories Supporting & Related Material Background Material 2016-06-02T04:00:00Z 2016 6     2016-06-02T18:16:30Z   0 0 090000648200a06c
FDA-2016-N-0436-0135 FDA None FDA-2016-N-0436 Exhibits A-M re: Comment from Karl Storz (Mintz Levin) Supporting & Related Material Electronic Regulation from Form 2016-06-02T04:00:00Z 2016 6     2016-06-02T20:19:37Z   0 0 090000648200b251
FDA-2016-N-0436-0110 FDA None FDA-2016-N-0436 Attachment B A Collective Risk Model for Health Systems AOs & NCAs re: Comment from Binseng Wang (Cover Letter) Supporting & Related Material Background Material 2016-06-02T04:00:00Z 2016 6     2016-06-02T18:16:30Z   0 0 090000648200aa1a
FDA-2016-N-0436-0111 FDA None FDA-2016-N-0436 Attachment C Answers to FDA Questions re: Comment from Binseng Wang (Cover Letter) Supporting & Related Material Background Material 2016-06-02T04:00:00Z 2016 6     2016-06-02T18:16:31Z   0 0 090000648200aa1d
FDA-2016-N-0436-0109 FDA None FDA-2016-N-0436 Attachment A Comments on FDA Proposed Definitions of Third-Party and OEM Activities re: Comment from Binseng Wang (Cover Letter) Supporting & Related Material Background Material 2016-06-02T04:00:00Z 2016 6     2016-06-02T18:16:30Z   0 0 090000648200a606
FDA-2016-N-0436-0089 FDA None FDA-2016-N-0436 Attachment 1 Consensus Body Approved Draft of ANSI RIC Standard re: Comment from Remanufacturing Industries Council (RIC) Supporting & Related Material Background Material 2016-06-02T04:00:00Z 2016 6     2016-06-02T18:18:17Z   0 0 090000648200a068
FDA-2016-N-0436-0039 FDA None FDA-2016-N-0436 Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third- Party Entities and Original Equipment Manufacturers; Extension of Comment Period Proposed Rule Extension of Comment Period 2016-04-25T04:00:00Z 2016 4 2016-04-25T04:00:00Z 2016-06-04T03:59:59Z 2016-06-10T01:00:31Z 2016-09443 0 0 0900006481f88f51
FDA-2016-N-0436-0019 FDA None FDA-2016-N-0436 Attachment 1 Fennigkoh-Managing Medical Equipment Risks re: Comment from Larry Fennigkoh Supporting & Related Material Background Material 2016-03-31T04:00:00Z 2016 3     2016-03-31T18:35:24Z   0 0 0900006481eef155
FDA-2016-N-0436-0001 FDA None FDA-2016-N-0436 Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third- Party Entities and Original Equipment Manufacturers; Request for Comments Proposed Rule Request for Comment 2016-03-04T05:00:00Z 2016 3 2016-03-04T05:00:00Z 2016-05-04T03:59:59Z 2016-05-06T19:00:24Z 2016-04700 0 0 0900006481ea097a

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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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