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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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