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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

6 rows where docket_id = "FDA-2022-N-0794" sorted by posted_date descending

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

document_type 3

  • Supporting & Related Material 4
  • Proposed Rule 1
  • Rule 1

posted_year 2

  • 2026 5
  • 2022 1

agency_id 1

  • FDA 6
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2022-N-0794-0025 FDA General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma FDA-2022-N-0794 Final Order Reference 4 - Requests for Feedback and Meetings for Medical Device Submissions - The Q-Submission Program Guidance for Industry Supporting & Related Material Background Material 2026-03-31T04:00:00Z 2026 3     2026-03-31T21:45:18Z   0 0 09000064b92479a3
FDA-2022-N-0794-0023 FDA General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma FDA-2022-N-0794 Final Order Reference 2 - P090012 Approval Order Supporting & Related Material Background Material 2026-03-31T04:00:00Z 2026 3     2026-03-31T21:45:11Z   0 0 09000064b92479a1
FDA-2022-N-0794-0022 FDA General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma FDA-2022-N-0794 Final Order Reference 1 - July 28-29 2022 Meeting of the General and Plastic Surgery Devices Panel Meeting Materials Supporting & Related Material Background Material 2026-03-31T04:00:00Z 2026 3     2026-03-31T21:45:07Z   0 0 09000064b92479a0
FDA-2022-N-0794-0024 FDA General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma FDA-2022-N-0794 Final Order Reference 3 - P150046 Approval Order Supporting & Related Material Background Material 2026-03-31T04:00:00Z 2026 3     2026-03-31T21:45:14Z   0 0 09000064b92479a2
FDA-2022-N-0794-0021 FDA General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma FDA-2022-N-0794 General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer Rule Final Rule 2026-03-25T04:00:00Z 2026 3     2026-03-25T23:46:39Z 2026-05772 0 0 09000064b9235032
FDA-2022-N-0794-0001 FDA General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma FDA-2022-N-0794 General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma Proposed Rule Amendment 2022-06-30T04:00:00Z 2022 6 2022-06-30T04:00:00Z 2022-08-30T03:59:59Z 2022-08-31T01:01:03Z 2022-13954 0 0 09000064851ab45e

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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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