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

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44 rows where docket_id = "FDA-2020-N-1053" sorted by posted_date descending

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document_type 3

  • Supporting & Related Material 42
  • Proposed Rule 1
  • Rule 1

posted_year 2

  • 2020 33
  • 2026 11

agency_id 1

  • FDA 44
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2020-N-1053-0048 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Final Order Ref 7 - P210016 Summary of Safety and Effectiveness Data Supporting & Related Material Background Material 2026-04-16T04:00:00Z 2026 4     2026-04-16T18:38:06Z   0 0 09000064b9283f37
FDA-2020-N-1053-0047 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Final Order Ref 6 - P230025 Summary of Safety and Effectiveness Data Supporting & Related Material Background Material 2026-04-16T04:00:00Z 2026 4     2026-04-16T18:38:03Z   0 0 09000064b9283f36
FDA-2020-N-1053-0041 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Rule Final Rule 2026-04-16T04:00:00Z 2026 4     2026-04-16T18:27:17Z 2026-07366 0 0 09000064b928652b
FDA-2020-N-1053-0044 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Final Order Ref 3 - Sep. 8-9 Meeting of the Orthopaedic and Rehabilitation Devices Panel Transcript Supporting & Related Material Background Material 2026-04-16T04:00:00Z 2026 4     2026-04-16T18:37:54Z   0 0 09000064b9283f09
FDA-2020-N-1053-0050 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Final Order Ref 9 - Guidance - 510(k) modifications Supporting & Related Material Background Material 2026-04-16T04:00:00Z 2026 4     2026-04-16T18:38:12Z   0 0 09000064b9283f39
FDA-2020-N-1053-0046 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Final Order Ref 5 - P210035 Summary of Safety and Effectiveness Data Supporting & Related Material Background Material 2026-04-16T04:00:00Z 2026 4     2026-04-16T18:38:00Z   0 0 09000064b9283f0b
FDA-2020-N-1053-0043 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Final Order Ref 1 - Sep. 8-9 Meeting of the Orthopaedic and Rehabilitation Devices Panel Materials Supporting & Related Material Background Material 2026-04-16T04:00:00Z 2026 4     2026-04-16T18:37:50Z   0 0 09000064b9283f08
FDA-2020-N-1053-0045 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Final Order Ref 4 - P190030 Summary of Safety and Effectiveness Data Supporting & Related Material Background Material 2026-04-16T04:00:00Z 2026 4     2026-04-16T18:37:57Z   0 0 09000064b9283f0a
FDA-2020-N-1053-0049 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Final Order Ref 8 - Guidance - The Q-Submission Program Supporting & Related Material Background Material 2026-04-16T04:00:00Z 2026 4     2026-04-16T18:38:09Z   0 0 09000064b9283f38
FDA-2020-N-1053-0042 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Final Order References Table of Contents (BGS) Supporting & Related Material Background Material 2026-04-16T04:00:00Z 2026 4     2026-04-16T18:36:50Z   0 0 09000064b9283f07
FDA-2020-N-1053-0051 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Final Order Ref 10 - Guidance - 510(k) software mods Supporting & Related Material Background Material 2026-04-16T04:00:00Z 2026 4     2026-04-16T18:38:17Z   0 0 09000064b9283f3a
FDA-2020-N-1053-0011 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 17 - Basset published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:21Z   0 0 0900006484814c68
FDA-2020-N-1053-0006 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 22 - Zamora-Navas published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:17Z   0 0 0900006484814c6d
FDA-2020-N-1053-0028 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 36 - Foley published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:09:21Z   0 0 0900006484814c81
FDA-2020-N-1053-0020 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 30 - Majeed published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:28Z   0 0 0900006484814ec5
FDA-2020-N-1053-0005 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 23 - Fourie published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:17Z   0 0 0900006484814c6e
FDA-2020-N-1053-0013 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 37 Streit published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:22Z   0 0 0900006484814c82
FDA-2020-N-1053-0033 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 12 - Yasuda published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:09:25Z   0 0 0900006484814e60
FDA-2020-N-1053-0014 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 16 - Becker published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:23Z   0 0 0900006484814e64
FDA-2020-N-1053-0009 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 19 - Garland published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:19Z   0 0 0900006484814c6a
FDA-2020-N-1053-0003 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 25 - DeVries published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:15Z   0 0 0900006484814c70
FDA-2020-N-1053-0012 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 38 - Aleem published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:21Z   0 0 0900006484814c83
FDA-2020-N-1053-0019 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 List of References FDA-2020-N-1053 Bone Growth Stimulator References re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:27Z   0 0 0900006484814e5f
FDA-2020-N-1053-0023 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 27 - Zura published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:30Z   0 0 0900006484814ec2
FDA-2020-N-1053-0032 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 15 - Dwyer published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:09:24Z   0 0 0900006484814e63
FDA-2020-N-1053-0018 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 32 - Biglari published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:26Z   0 0 0900006484814ec9
FDA-2020-N-1053-0004 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 24 - Phillips published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:16Z   0 0 0900006484814c6f
FDA-2020-N-1053-0015 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 35 - Murray published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:24Z   0 0 0900006484814c7e
FDA-2020-N-1053-0008 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 20 - Scott published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:19Z   0 0 0900006484814c6b
FDA-2020-N-1053-0024 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 42 - Hannemann published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:09:19Z   0 0 0900006484814c87
FDA-2020-N-1053-0016 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 14 - Friedenberg published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:25Z   0 0 0900006484814e62
FDA-2020-N-1053-0031 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 31 - Mizra published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:09:23Z   0 0 0900006484814ec8
FDA-2020-N-1053-0002 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 26 - Zura published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:15Z   0 0 0900006484814c71
FDA-2020-N-1053-0027 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 39 - Behrens published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:09:21Z   0 0 0900006484814c84
FDA-2020-N-1053-0021 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 29 - Elvey published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:28Z   0 0 0900006484814ec4
FDA-2020-N-1053-0029 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Referece 34 - Assiotis published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:09:22Z   0 0 0900006484814ecb
FDA-2020-N-1053-0017 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 13 - Basset published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:25Z   0 0 0900006484814e61
FDA-2020-N-1053-0022 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 28 - Nolte published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:29Z   0 0 0900006484814ec3
FDA-2020-N-1053-0030 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 33 - Coric published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:09:23Z   0 0 0900006484814eca
FDA-2020-N-1053-0007 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 21 - Abeed published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:18Z   0 0 0900006484814c6c
FDA-2020-N-1053-0025 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 41 - Griffin re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:09:20Z   0 0 0900006484814c86
FDA-2020-N-1053-0010 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 18 - Adams published article re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:08:20Z   0 0 0900006484814c69
FDA-2020-N-1053-0026 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Reference 40 - Griffin re Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Supporting & Related Material Background Material 2020-08-20T04:00:00Z 2020 8     2020-08-20T18:09:20Z   0 0 0900006484814c85
FDA-2020-N-1053-0001 FDA Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators FDA-2020-N-1053 Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Proposed Rule Notice of Proposed Rulemaking (NPRM) 2020-08-17T04:00:00Z 2020 8 2020-08-17T04:00:00Z 2020-10-17T03:59:59Z 2020-10-17T01:03:54Z 2020-17543 0 0 0900006484807e50

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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
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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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