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

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41 rows where docket_id = "FDA-2001-N-0178" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2001-N-0178-0053 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff Other Guidance 2023-02-22T05:00:00Z 2023 2 2023-02-22T05:00:00Z   2024-11-07T00:47:49Z   1 0 09000064856e13af
FDA-2001-N-0178-0052 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide Other Guidance 2023-02-22T05:00:00Z 2023 2 2023-02-22T05:00:00Z   2023-02-22T14:25:08Z   0 0 09000064845683d4
FDA-2001-N-0178-0041 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Attachment 1 Gofman 2002 What Are the Main Critiques of the 1999 Study re: Comment from John W. Gofman Supporting & Related Material Background Material 2016-02-03T05:00:00Z 2016 2     2016-02-03T15:03:20Z   0 0 0900006481e4a4f9
FDA-2001-N-0178-0043 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Attachment 3 Gofman 1999, Executive Summary re: Comment from John W. Gofman Supporting & Related Material Background Material 2016-02-03T05:00:00Z 2016 2     2016-02-03T15:07:54Z   0 0 0900006481e4a4fb
FDA-2001-N-0178-0042 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Attachment 2 Critique by Arthur C. Upton re: Comment from John W. Gofman Supporting & Related Material Background Material 2016-02-03T05:00:00Z 2016 2     2016-02-03T15:05:26Z   0 0 0900006481e4a4fa
FDA-2001-N-0178-0011 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 2 FDA Guidance Document Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T14:55:55Z   0 0 0900006481e42afa
FDA-2001-N-0178-0024 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 25 Gkanatsios, et al evaluation of an On-Line Patient Exposure Meter in Neuroradiology re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:13:34Z   0 0 09000064804e15af
FDA-2001-N-0178-0033 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Tab B Changes of Initial Draft (FRN) Submitted to OIRA for Review and Action re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:23:32Z   0 0 09000064804e15df
FDA-2001-N-0178-0015 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 17 Council Directive 97/43 euration Health Protection of Individuals Against the Dangers of Ionizing Radiation in Relation to Medical Exposure re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T16:23:45Z   0 0 0900006481e427ab
FDA-2001-N-0178-0012 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 9 FDA CDRH Handbook of Selected Tissue Doses for Fluoroscopic and Cineangiographic Examination of the Coronary Arteries re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T15:21:49Z   0 0 0900006481e42af4
FDA-2001-N-0178-0027 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 29 Stern et al Estimated Benefits of Proposed Amendments to the FDA Radiation-Safety Standard for Diagnostic X-ray Equipment 2001 FDA Science Forum, Wash, DC, February 15 thru 16, 2001 re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:16:26Z   0 0 09000064804e15aa
FDA-2001-N-0178-0025 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 26 Geise, R. et al Radiation Doses during Pediatric Radiofrequency Catheter Ablation Procedures, PACE re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:14:04Z   0 0 09000064804e15ad
FDA-2001-N-0178-0028 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 30 Committee on Interagency Radiation Research and Policy Coordination Science Use of BEIR V AND UNSCEAR 1988 in Radiation Risk Assessment, December 1992 re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:16:56Z   0 0 09000064804e15c6
FDA-2001-N-0178-0029 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 31 Sources and Effects of Ionizing Radiation United Nations Scientific Committee on the Effects of Atomic Radiation re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:17:52Z   0 0 09000064804e15c9
FDA-2001-N-0178-0031 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Memorandum from OMB OIRA to FDA DDM Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:22:39Z   0 0 09000064804e15e9
FDA-2001-N-0178-0018 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 20 FDA Recording Information in the Patient's Medical Record that Identifies the Potential for Serious X-ray Induced Skin Injuries Following Fluoroscopically Guided Procedures re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:01:06Z   0 0 0900006481e427a8
FDA-2001-N-0178-0020 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 8 Proceedings of the ACR/FDA Workshop on Fluroscopy Strategies for Improvement in Performance, Radiation Safety and Control October 16 & 17, 1992 re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Part 2 of 3 Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:06:42Z   0 0 09000064804e15d4
FDA-2001-N-0178-0026 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 27 Transcript of Proceedings Twenty-fifth Meeting of the Technical Electronic Product Radiation Safety Standards Committee September 1998 re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:14:40Z   0 0 09000064804e15c4
FDA-2001-N-0178-0017 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 19 FDA Public Health Advisory: Avoidance of Serious x-ray Induced Skin Injuries to Patients during Fluoroscopically-Guided Procedures re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T16:53:47Z   0 0 0900006481e427a9
FDA-2001-N-0178-0021 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 8 Proceedings of the ACR/FDA Workshop on Fluroscopy Strategies for Improvement in Performance, Radiation Safety and Control October 16 & 17, 1992 re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Part 3 of 3 Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:06:56Z   0 0 09000064804e15dc
FDA-2001-N-0178-0034 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Memorandum from OMB OIRA to FDA DDM Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:25:19Z   0 0 09000064804e1639
FDA-2001-N-0178-0019 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 8 Proceedings of the ACR/FDA Workshop on Fluroscopy Strategies for Improvement in Performance, Radiation Safety and Control October 16 & 17, 1992 re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Part 1 of 3 Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:06:26Z   0 0 09000064804e15d0
FDA-2001-N-0178-0016 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 18 FDA Avoidance of Serious X-ray Induced Skin Injuries to Patients during Fluoroscopically-Guided Procedures re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T16:35:41Z   0 0 0900006481e427aa
FDA-2001-N-0178-0013 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 10 Rudin and Bednarek Spatial Shaping of the Beam: Collimation, Grids, Equalization Filters, and Region-of-Interest Fluoroscopy re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T15:27:20Z   0 0 0900006481e42af3
FDA-2001-N-0178-0014 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 11 Solomon et al Low-exposure Scanning-beam X-ray Fluoroscopy System re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T15:31:58Z   0 0 0900006481e42af2
FDA-2001-N-0178-0023 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 23 Bauml, et al Joint WHO/ISH Workshop on Efficacy and Radiation safety in Interventional Radiology re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:12:27Z   0 0 09000064804e15b2
FDA-2001-N-0178-0036 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Tab B Changes of Initial Draft (FRN 70FR33998) Submitted to OMB OIRA for Review and Action re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:26:14Z   0 0 09000064804e1634
FDA-2001-N-0178-0030 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 33 FDA CDRH November 15, 2000 Assessment of the Impact of the Proposed Amendments to the Diagnostic X-ray Equipment Performance Standard Addressing Fluoroscopic X-ray Systems re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:19:54Z   0 0 09000064804e15cd
FDA-2001-N-0178-0022 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Reference 21 Rosenstein, M. et al., DHHS FDA Handbook of Selected Tissue Doses for the Upper Gastrointestinal Fluoroscopic Examination re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:10:35Z   0 0 09000064804e15be
FDA-2001-N-0178-0035 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Tab A Initial Draft (FRN 70FR33998) Submitted to OMB OIRA for Review re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:25:47Z   0 0 09000064804e163b
FDA-2001-N-0178-0032 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Tab A Initial Draft (FRN) Submitted to OMB OIRA for Review re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-02T05:00:00Z 2016 2     2016-02-02T17:23:06Z   0 0 09000064804e15e4
FDA-2001-N-0178-0010 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 List of References re: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Supporting & Related Material Background Material 2016-02-01T05:00:00Z 2016 2     2016-02-01T17:13:23Z   0 0 09000064804e15d8
FDA-2001-N-0178-0009 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components; Correction Proposed Rule Correction 2015-03-17T04:00:00Z 2015 3     2016-02-01T17:10:32Z   0 0 09000064804e1595
FDA-2001-N-0178-0008 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Letter from FDA CDRH to GE OEC Medical Systems, Inc. Other Letter(s) 2006-05-08T04:00:00Z 2006 5     2016-02-02T17:47:04Z   0 0 09000064804e164b
FDA-2001-N-0178-0007 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Letter from FDA CDRH to GE Heathcare Other Letter(s) 2006-05-08T04:00:00Z 2006 5     2016-02-02T17:43:54Z   0 0 09000064804e1648
FDA-2001-N-0178-0006 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Notice Notice of Approval 2005-06-30T04:00:00Z 2005 6 2005-06-29T04:00:00Z 2007-01-01T04:59:59Z 2016-02-02T17:35:36Z   0 0 09000064804e1632
FDA-2001-N-0178-0005 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Cover Sheet for Supporting Statement Supporting & Related Material Background Material 2005-06-30T04:00:00Z 2005 6     2016-02-03T16:20:48Z   0 0 09000064804e162f
FDA-2001-N-0178-0004 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Supporting Statement for Performance Standard for Diagnostic X-RAY Systems and Their Major Components Supporting & Related Material Background Material 2005-06-30T04:00:00Z 2005 6     2016-02-03T16:16:57Z   0 0 09000064804e162d
FDA-2001-N-0178-0003 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Pages 101 through 170 Rule Notice of Final Rule 2005-06-21T04:00:00Z 2005 6 2005-06-09T04:00:00Z   2016-02-02T17:30:52Z 70FR33998 0 0 09000064804e1628
FDA-2001-N-0178-0002 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Pages 1 through 100 Rule Notice of Final Rule 2005-06-21T04:00:00Z 2005 6 2005-06-09T04:00:00Z   2016-02-02T17:29:43Z   0 0 09000064804e1623
FDA-2001-N-0178-0001 FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components FDA-2001-N-0178 Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components Proposed Rule Notice of Proposed Rulemaking (NPRM) 2002-12-10T05:00:00Z 2002 12 2002-12-10T05:00:00Z 2003-04-10T03:59:59Z 2016-02-03T22:01:16Z   0 0 09000064804e1548

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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);