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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

12 rows where docket_id = "FDA-2010-D-0226" 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 4

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2010-D-0226-0031 FDA None FDA-2010-D-0226 Reference 4, Notice - Canadian Medical Device Conformity Assessment System Supporting & Related Material Reference (external attachments) 2015-12-17T05:00:00Z 2015 12     2015-12-17T15:58:39Z   0 0 0900006481db7469
FDA-2010-D-0226-0027 FDA None FDA-2010-D-0226 Medical Device ISO 13485: 2003 Voluntary Audit Report Pilot Program; Termination of Pilot Program; Announcement of the Medical Device Single Audit Program Operational Phase List of References Supporting & Related Material List 2015-12-17T05:00:00Z 2015 12     2015-12-17T15:48:23Z   0 0 0900006481db740f
FDA-2010-D-0226-0026 FDA None FDA-2010-D-0226 Medical Device ISO 13485:2003 Voluntary Audit Report Pilot Program; Termination of Pilot Program; Announcement of the Medical Device Single Audit Program Operational Phase Notice Notice of Termination 2015-12-17T05:00:00Z 2015 12 2015-12-17T05:00:00Z   2015-12-17T15:07:46Z 2015-31692 0 0 0900006481db6ac6
FDA-2010-D-0226-0029 FDA None FDA-2010-D-0226 Reference 2, Medical Device Single Audit Program (MDSAP) Mid-Pilot Status Report Supporting & Related Material Reference (internal unless indicated) 2015-12-17T05:00:00Z 2015 12     2015-12-17T15:52:30Z   0 0 0900006481db7465
FDA-2010-D-0226-0030 FDA None FDA-2010-D-0226 Reference 3, Medical Device Single Audit Program (MDSAP) Pilot Supporting & Related Material Reference (internal unless indicated) 2015-12-17T05:00:00Z 2015 12     2015-12-17T15:55:32Z   0 0 0900006481db7467
FDA-2010-D-0226-0028 FDA None FDA-2010-D-0226 Reference 1, Guidance for Industry, Third Parties and Food and Drug Administration Staff Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program Supporting & Related Material Reference (internal unless indicated) 2015-12-17T05:00:00Z 2015 12     2015-12-17T15:47:18Z   0 0 0900006481db753e
FDA-2010-D-0226-0022 FDA None FDA-2010-D-0226 Guidance for Industry, Third Parties and Staff; Availability: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program Notice Notice of Availability 2012-03-19T04:00:00Z 2012 3 2012-03-19T04:00:00Z   2012-03-19T18:51:48Z 2012-06503 0 0 0900006480fdacf6
FDA-2010-D-0226-0023 FDA None FDA-2010-D-0226 Guidance for Industry, Third Parties and Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program Other Guidance 2012-03-19T04:00:00Z 2012 3 2012-03-19T04:00:00Z   2024-11-07T22:35:04Z   1 0 0900006480fdb2bd
FDA-2010-D-0226-0021 FDA None FDA-2010-D-0226 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Draft Guidance on Voluntary Audit Report Submission Notice General Notice 2011-07-07T04:00:00Z 2011 7 2011-07-07T04:00:00Z 2011-08-09T03:59:59Z 2011-07-07T15:17:21Z 2011-17051 0 0 0900006480ebb6db
FDA-2010-D-0226-0014 FDA None FDA-2010-D-0226 AdvaMed Audit Report Format Template, 4/23/2009 - [Advanced Medical Technology Association (AdvaMed) - Comment] re 2010-D-0226-0010 Supporting & Related Material C-Comment (Supporting and Related Material) 2010-07-30T04:00:00Z 2010 7     2012-03-24T19:37:07Z   0 0 0900006480b2142b
FDA-2010-D-0226-0001 FDA None FDA-2010-D-0226 Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff: Medical Device Voluntary Audit Report Submission Program; Availability Notice NAD-Notice of Availability of Data 2010-05-20T04:00:00Z 2010 5 2010-05-20T04:00:00Z 2010-08-19T03:59:59Z 2010-05-20T14:21:55Z 2010-12098 0 0 0900006480af1400
FDA-2010-D-0226-0002 FDA None FDA-2010-D-0226 Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff: Medical Device Voluntary Audit Report Submission Program; Availability Other GDL-Guidance (Supporting and Related Materials) 2010-05-20T04:00:00Z 2010 5 2010-05-20T04:00:00Z 2010-08-19T03:59:59Z 2010-05-20T14:25:42Z   0 0 0900006480af1462

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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;