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

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35 rows where docket_id = "FDA-2021-N-0555" and posted_year = 2021 sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 34
  • Proposed Rule 1

posted_year 1

  • 2021 · 35 ✖

agency_id 1

  • FDA 35
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2021-N-0555-0137 FDA None FDA-2021-N-0555 EA Reference 14 - FN - Duracell Hearing Aid Batteries RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:55:05Z   0 0 0900006484e06a42
FDA-2021-N-0555-0140 FDA None FDA-2021-N-0555 EA Reference 7 - FN - Universal Waste RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:55:26Z   0 0 0900006484e06a45
FDA-2021-N-0555-0143 FDA None FDA-2021-N-0555 PRIA Reference 6 - FDA Labeling Cost Model RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:55:50Z   0 0 0900006484e06a48
FDA-2021-N-0555-0145 FDA None FDA-2021-N-0555 EA Reference 9 - FN - What are the benefits of rechargeable batteries RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:56:02Z   0 0 0900006484e06a4a
FDA-2021-N-0555-0127 FDA None FDA-2021-N-0555 List of References RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:51:41Z   0 0 0900006484e04e62
FDA-2021-N-0555-0138 FDA None FDA-2021-N-0555 PRIA Reference 3 - Online Shopping and E-Commerce RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:55:12Z   0 0 0900006484e06a43
FDA-2021-N-0555-0141 FDA None FDA-2021-N-0555 Proposed FONSI Environmental Assessment RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:55:32Z   0 0 0900006484e06a46
FDA-2021-N-0555-0135 FDA None FDA-2021-N-0555 EA Reference 4 - Electronic Waste Management Approaches RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:54:51Z   0 0 0900006484e04e6a
FDA-2021-N-0555-0132 FDA None FDA-2021-N-0555 Reference 15 - Presentation on the Work of the CTA PSAP Standard Committee RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:54:07Z   0 0 0900006484e04e67
FDA-2021-N-0555-0136 FDA None FDA-2021-N-0555 EA Reference 8 - FN - Mercury in Batteries RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:54:58Z   0 0 0900006484e06a41
FDA-2021-N-0555-0134 FDA None FDA-2021-N-0555 EA Reference 12 - FN - Hearing Loss and Hearing Aid Use Infographic RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:54:20Z   0 0 0900006484e04e69
FDA-2021-N-0555-0148 FDA None FDA-2021-N-0555 EA Reference 5 - Advancing Sustainable Materials Management RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:56:25Z   0 0 0900006484e06a4d
FDA-2021-N-0555-0129 FDA None FDA-2021-N-0555 Reference 10 - HLAA Response to Call for Comment RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:53:46Z   0 0 0900006484e04e64
FDA-2021-N-0555-0139 FDA None FDA-2021-N-0555 EA Reference 13 - FN - Hearing Aids Cost More Than Their Weight in Gold RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:55:19Z   0 0 0900006484e06a44
FDA-2021-N-0555-0130 FDA None FDA-2021-N-0555 Reference 8 - Conditions for Sale for Air-Conduction Hearing Aids IIE Guidance RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:53:54Z   0 0 0900006484e04e65
FDA-2021-N-0555-0133 FDA None FDA-2021-N-0555 EA Reference 11 - FN - FAQ About Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:54:14Z   0 0 0900006484e04e68
FDA-2021-N-0555-0131 FDA None FDA-2021-N-0555 PRIA Reference 4 - How Long Do Hearing Aids Last RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:54:01Z   0 0 0900006484e04e66
FDA-2021-N-0555-0146 FDA None FDA-2021-N-0555 Reference 16 - The Potential Risk of Using PSAPs RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:56:08Z   0 0 0900006484e06a4b
FDA-2021-N-0555-0128 FDA None FDA-2021-N-0555 Reference 23 - PRIA for OTC Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:51:47Z   0 0 0900006484e04e63
FDA-2021-N-0555-0142 FDA None FDA-2021-N-0555 EA Reference 10 - FN - How Long Do Hearing Aid Batteries Last RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:55:43Z   0 0 0900006484e06a47
FDA-2021-N-0555-0149 FDA None FDA-2021-N-0555 PRIA Reference 7 - NAICS 325400 Pharmaceutical and Medical Manufacturing RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:56:33Z   0 0 0900006484e06a4e
FDA-2021-N-0555-0144 FDA None FDA-2021-N-0555 PRIA Reference 1 - The Big Six Hearing Aid Companies RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:55:56Z   0 0 0900006484e06a49
FDA-2021-N-0555-0147 FDA None FDA-2021-N-0555 PRIA Reference 2 - 20Q - 25 Years of MarkeTrak RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-11-02T04:00:00Z 2021 11     2021-11-02T13:56:18Z   0 0 0900006484e06a4c
FDA-2021-N-0555-0003 FDA None FDA-2021-N-0555 Reference 2 - Impact of Hearing Loss on Quality of Life in Older Adults RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-10-21T04:00:00Z 2021 10     2021-11-02T13:45:16Z   0 0 0900006484dcec41
FDA-2021-N-0555-0010 FDA None FDA-2021-N-0555 Reference 20 - NASEM Committee Looks at Regulation for OTC Hearing Devices RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-10-21T04:00:00Z 2021 10     2021-11-02T13:46:17Z   0 0 0900006484dcec40
FDA-2021-N-0555-0006 FDA None FDA-2021-N-0555 Reference 4 - Why do people fitted with hearing aids not wear them RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-10-21T04:00:00Z 2021 10     2021-11-02T13:45:43Z   0 0 0900006484dcec42
FDA-2021-N-0555-0008 FDA None FDA-2021-N-0555 Reference 13 - ANSI-CTA 2051 2017 (FINAL) RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-10-21T04:00:00Z 2021 10     2021-11-02T13:46:00Z   0 0 0900006484dcec43
FDA-2021-N-0555-0012 FDA None FDA-2021-N-0555 Reference 22 - PSAPs v Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-10-21T04:00:00Z 2021 10     2021-11-02T13:46:57Z   0 0 0900006484dcfbd7
FDA-2021-N-0555-0011 FDA None FDA-2021-N-0555 Reference 21 - The Compression Handbook RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-10-21T04:00:00Z 2021 10     2021-11-02T13:46:25Z   0 0 0900006484dcfbd8
FDA-2021-N-0555-0002 FDA None FDA-2021-N-0555 Reference 1 - Hearing Loss Prevalence in the US RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-10-21T04:00:00Z 2021 10     2021-11-02T13:44:58Z   0 0 0900006484dcec3f
FDA-2021-N-0555-0005 FDA None FDA-2021-N-0555 Reference 3b - Can Hearing Aids Delay Time to Diagnosis of Dementia etc RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-10-21T04:00:00Z 2021 10     2021-11-02T13:45:35Z   0 0 0900006484dcfbd6
FDA-2021-N-0555-0009 FDA None FDA-2021-N-0555 Reference 18 - Theoretical and Practical Considerations in Compression Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-10-21T04:00:00Z 2021 10     2021-11-02T13:46:08Z   0 0 0900006484dcfbd9
FDA-2021-N-0555-0007 FDA None FDA-2021-N-0555 Reference 6 - Hearing Health Care for Adults Priorities for Improving Access and Affordability RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-10-21T04:00:00Z 2021 10     2021-11-02T13:45:52Z   0 0 0900006484dcfbda
FDA-2021-N-0555-0004 FDA None FDA-2021-N-0555 Reference 3a - Longitudinal Relationship Between Hearing Aid Use and Cognitive Function in Older Americans RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Supporting & Related Material Background Material 2021-10-21T04:00:00Z 2021 10     2021-11-02T13:45:25Z   0 0 0900006484dcfbd5
FDA-2021-N-0555-0001 FDA None FDA-2021-N-0555 Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids Proposed Rule Advance Notice of Proposed Rulemaking (ANPRM) 2021-10-20T04:00:00Z 2021 10 2021-10-20T04:00:00Z 2022-01-19T04:59:59Z 2022-09-19T18:22:50Z 2021-22473 0 0 0900006484dceaeb

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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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