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

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40 rows where docket_id = "FDA-2018-N-0236" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2018-N-0236-0055 FDA None FDA-2018-N-0236 Reference 20 - Final Regulatory Flexibility Analysis 5 Oct 2021 Supporting & Related Material Background Material 2021-10-19T04:00:00Z 2021 10     2021-10-19T14:16:28Z   0 0 0900006484dcb011
FDA-2018-N-0236-0037 FDA None FDA-2018-N-0236 Ref 6 - CDRH Patient Engagement web page RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T19:57:53Z   0 0 0900006484dbb09a
FDA-2018-N-0236-0036 FDA None FDA-2018-N-0236 Ref 5 - De Novo Classification Process (Evaluation of Automatic Class III Designation) RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T19:55:01Z   0 0 0900006484dbb09b
FDA-2018-N-0236-0038 FDA None FDA-2018-N-0236 Ref 7 - Procedures for Meetings of the Medical Devices Advisory Committee RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T19:59:35Z   0 0 0900006484dbb0d6
FDA-2018-N-0236-0049 FDA None FDA-2018-N-0236 RIA Ref 1 Proposed Rule RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:13:38Z   0 0 0900006484dbb0e2
FDA-2018-N-0236-0054 FDA None FDA-2018-N-0236 RIA Ref 6 Medical_Devices_Top_Markets_Report RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:18:23Z   0 0 0900006484dbb0e4
FDA-2018-N-0236-0053 FDA None FDA-2018-N-0236 RIA Ref 5 NAICS 339100 May 2019 BLS OES RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:17:23Z   0 0 0900006484dbb0e6
FDA-2018-N-0236-0039 FDA None FDA-2018-N-0236 Ref 8 - eCopy Program for Medical Device Submissions RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:00:28Z   0 0 0900006484dbb0d8
FDA-2018-N-0236-0050 FDA None FDA-2018-N-0236 RIA Ref 2 Preliminary RIA RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:14:57Z   0 0 0900006484dbb0e1
FDA-2018-N-0236-0028 FDA None FDA-2018-N-0236 Medical Device De Novo Classification Process Rule Final Rule 2021-10-05T04:00:00Z 2021 10 2021-10-05T04:00:00Z   2021-10-05T16:21:46Z 2021-21677 0 0 0900006484dbaa56
FDA-2018-N-0236-0030 FDA None FDA-2018-N-0236 Ref 2 - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T19:46:08Z   0 0 0900006484dbb099
FDA-2018-N-0236-0031 FDA None FDA-2018-N-0236 Ref 1 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T19:46:54Z   0 0 0900006484dbb09c
FDA-2018-N-0236-0052 FDA None FDA-2018-N-0236 RIA Ref 4 HHS_RIAGuidance RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:16:33Z   0 0 0900006484dbb0e5
FDA-2018-N-0236-0029 FDA None FDA-2018-N-0236 Medical Device De Novo Classification Process Final Rule References List re: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T19:44:02Z   0 0 0900006484dbb098
FDA-2018-N-0236-0032 FDA None FDA-2018-N-0236 Ref 3 - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T19:55:35Z   0 0 0900006484dbb09d
FDA-2018-N-0236-0035 FDA None FDA-2018-N-0236 Ref 4-Patient Preference Information--Voluntary Submission Review in Premarket Approval Applications Humanitarian Device Exemption Applications and De Novo Req RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T19:56:47Z   0 0 0900006484dbb09e
FDA-2018-N-0236-0040 FDA None FDA-2018-N-0236 Ref 11 - Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:02:01Z   0 0 0900006484dbb0d5
FDA-2018-N-0236-0046 FDA None FDA-2018-N-0236 Ref 17 - User Fees for 513(g) Requests for Information RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:09:37Z   0 0 0900006484dbb0d7
FDA-2018-N-0236-0042 FDA None FDA-2018-N-0236 Ref 13 - Requests for Feedback and Meetings for Medical Device Submissions - The Q-Submission Program RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:04:49Z   0 0 0900006484dbb0db
FDA-2018-N-0236-0048 FDA None FDA-2018-N-0236 Ref 19 - Emergency Use Authorization of Medical Products and Related Authorities RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:11:44Z   0 0 0900006484dbb0e0
FDA-2018-N-0236-0034 FDA None FDA-2018-N-0236 Ref 10 - The 510(k) Program- Evaluating Substantial Equivalence in Premarket Notifications (510(k)) RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T19:56:38Z   0 0 0900006484dbb0da
FDA-2018-N-0236-0041 FDA None FDA-2018-N-0236 Ref 12 - The Least Burdensome Provisions- Concept and Principles RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:04:01Z   0 0 0900006484dbb0d9
FDA-2018-N-0236-0045 FDA None FDA-2018-N-0236 Ref 16 - Acceptance Review for De Novo Classification Requests RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:08:40Z   0 0 0900006484dbb0dd
FDA-2018-N-0236-0044 FDA None FDA-2018-N-0236 Ref 15 - Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:07:31Z   0 0 0900006484dbb0df
FDA-2018-N-0236-0051 FDA None FDA-2018-N-0236 RIA Ref 3 Ross Ginsburg 2003 RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:15:48Z   0 0 0900006484dbb0e3
FDA-2018-N-0236-0033 FDA None FDA-2018-N-0236 Ref 9 - Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals De Novo Classifications and Humanitarian Device RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T19:56:30Z   0 0 0900006484dbb09f
FDA-2018-N-0236-0047 FDA None FDA-2018-N-0236 Ref 18 - FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food Drug and Cosmetic Act RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:10:46Z   0 0 0900006484dbb0dc
FDA-2018-N-0236-0043 FDA None FDA-2018-N-0236 Ref 14 - Use of Electronic Health Record Data in Clinical Investigations RE: Medical Device De Novo Classification Process Supporting & Related Material Background Material 2021-10-05T04:00:00Z 2021 10     2021-10-05T20:05:59Z   0 0 0900006484dbb0de
FDA-2018-N-0236-0010 FDA None FDA-2018-N-0236 06 - Reference 5 - FDA's guidance Collection of Race and Ethnicity Data in Clinical Trials Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:28:59Z   0 0 090000648390d0be
FDA-2018-N-0236-0014 FDA None FDA-2018-N-0236 10 - Reference 9 - Patient Preference Information--Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests . . . Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:32:11Z   0 0 090000648390d0c2
FDA-2018-N-0236-0009 FDA None FDA-2018-N-0236 05 - Reference 4 - FDA's Guidance Collection of Race and Ethnicity Data in Clinical Trials Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:28:19Z   0 0 090000648390d0bd
FDA-2018-N-0236-0013 FDA None FDA-2018-N-0236 09 - Reference 8 - FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-26T20:09:39Z   0 0 090000648390d0c1
FDA-2018-N-0236-0005 FDA None FDA-2018-N-0236 01 - List of References Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:25:30Z   0 0 090000648390cc75
FDA-2018-N-0236-0015 FDA None FDA-2018-N-0236 11 - Reference 10 - Preliminary Analysis of Economic Impacts Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-26T19:59:25Z   0 0 090000648390d0c3
FDA-2018-N-0236-0006 FDA None FDA-2018-N-0236 02 - Reference 1 - De Novo Classification Process (Evaluation of Automatic Class III Designation) - Final Guidance Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-26T19:59:00Z   0 0 090000648390cc76
FDA-2018-N-0236-0012 FDA None FDA-2018-N-0236 08 - Reference 7 - Use of International Standard ISO-10993, Biological evaluation of medical devices--Part 1- Evaluation and testing within a risk management process Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:30:25Z   0 0 090000648390d0c0
FDA-2018-N-0236-0011 FDA None FDA-2018-N-0236 07 - Reference 6 - FDA's guidance Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:29:43Z   0 0 090000648390d0bf
FDA-2018-N-0236-0008 FDA None FDA-2018-N-0236 04 - Reference 3 - FDA's guidance - eCopy Program for Medical Device Submissions Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-15T19:27:37Z   0 0 090000648390cc78
FDA-2018-N-0236-0007 FDA None FDA-2018-N-0236 03 - Reference 2 - FDA's guidance "Procedures for Class II Device Exemptions from Premarket Notification" Supporting & Related Material Background Material 2019-02-15T05:00:00Z 2019 2     2019-02-26T19:31:29Z   0 0 090000648390cc77
FDA-2018-N-0236-0001 FDA None FDA-2018-N-0236 Medical Device De Novo Classification Process Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-12-07T05:00:00Z 2018 12 2018-12-07T05:00:00Z 2019-03-08T04:59:59Z 2019-03-09T02:01:03Z 2018-26378 0 0 090000648395870c

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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;