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28 rows where docket_id = "FDA-2018-N-0236" and posted_year = 2021 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 |
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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;