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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

5 rows where docket_id = "FDA-2026-P-1819" sorted by posted_date descending

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Suggested facets: subtype, open_for_comment, posted_date (date), comment_start_date (date), last_modified (date)

document_type 2

  • Supporting & Related Material 3
  • Other 2

posted_year 1

  • 2026 5

agency_id 1

  • FDA 5
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2026-P-1819-0004 FDA Request that the FDA Immediately Rescind or Amend 510(k) Clearance K252675 (December 15, 2025) for the da Vinci SP Surgical System by Removing Nipple Sparing Mastectomy (NSM) Procedures from Indications for Use Until Long-Term Oncologic Safety and Non-Inferiority Data Are Established, Restore the 2019 and 2021 Safety Communications, Issue Updated Guidance, and Conduct FDA-2026-P-1819 Exhibit A Supporting & Related Material Background Material 2026-02-19T05:00:00Z 2026 2     2026-02-19T23:12:34Z   0 0 09000064b91bf192
FDA-2026-P-1819-0003 FDA Request that the FDA Immediately Rescind or Amend 510(k) Clearance K252675 (December 15, 2025) for the da Vinci SP Surgical System by Removing Nipple Sparing Mastectomy (NSM) Procedures from Indications for Use Until Long-Term Oncologic Safety and Non-Inferiority Data Are Established, Restore the 2019 and 2021 Safety Communications, Issue Updated Guidance, and Conduct FDA-2026-P-1819 Exhibit 1 Supporting & Related Material Background Material 2026-02-19T05:00:00Z 2026 2     2026-03-04T00:30:47Z   0 0 09000064b91bf191
FDA-2026-P-1819-0005 FDA Request that the FDA Immediately Rescind or Amend 510(k) Clearance K252675 (December 15, 2025) for the da Vinci SP Surgical System by Removing Nipple Sparing Mastectomy (NSM) Procedures from Indications for Use Until Long-Term Oncologic Safety and Non-Inferiority Data Are Established, Restore the 2019 and 2021 Safety Communications, Issue Updated Guidance, and Conduct FDA-2026-P-1819 Exhibit B Supporting & Related Material Background Material 2026-02-19T05:00:00Z 2026 2     2026-02-19T23:12:38Z   0 0 09000064b91bf193
FDA-2026-P-1819-0001 FDA Request that the FDA Immediately Rescind or Amend 510(k) Clearance K252675 (December 15, 2025) for the da Vinci SP Surgical System by Removing Nipple Sparing Mastectomy (NSM) Procedures from Indications for Use Until Long-Term Oncologic Safety and Non-Inferiority Data Are Established, Restore the 2019 and 2021 Safety Communications, Issue Updated Guidance, and Conduct FDA-2026-P-1819 Citizen Petition from Harmed Americans for Reform in Medical-Device Safety Corp. Other Citizen Petition 2026-02-19T05:00:00Z 2026 2 2026-02-19T05:00:00Z   2026-02-19T23:11:29Z   1 0 09000064b91be1cf
FDA-2026-P-1819-0002 FDA Request that the FDA Immediately Rescind or Amend 510(k) Clearance K252675 (December 15, 2025) for the da Vinci SP Surgical System by Removing Nipple Sparing Mastectomy (NSM) Procedures from Indications for Use Until Long-Term Oncologic Safety and Non-Inferiority Data Are Established, Restore the 2019 and 2021 Safety Communications, Issue Updated Guidance, and Conduct FDA-2026-P-1819 Acknowledgment Letter from FDA DMB to Harmed Americans for Reform in Medical-Device Safety Corp. Other Acknowledgement Letter/Receipt 2026-02-19T05:00:00Z 2026 2 2026-02-19T05:00:00Z   2026-02-19T23:11:34Z   0 0 09000064b91be1d2

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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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