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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, null, null, "2021-10-05T19:59:35Z", null, 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, null, null, "2021-10-05T20:13:38Z", null, 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, null, null, "2021-10-05T20:18:23Z", null, 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, null, null, "2021-10-05T20:17:23Z", null, 0, 0, "0900006484dbb0e6"], ["FDA-2018-N-0236-0039", "FDA", "FDA-2018-N-0236", "Ref 8 - 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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, null, null, "2021-10-05T19:46:54Z", null, 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, null, null, "2021-10-05T20:16:33Z", null, 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, null, null, "2021-10-05T19:44:02Z", null, 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, null, null, "2021-10-05T19:55:35Z", null, 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, null, null, "2021-10-05T19:56:47Z", null, 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, null, null, "2021-10-05T20:02:01Z", null, 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, null, null, "2021-10-05T20:09:37Z", null, 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, null, null, "2021-10-05T20:04:49Z", null, 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, null, null, "2021-10-05T20:11:44Z", null, 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, null, null, "2021-10-05T19:56:38Z", null, 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, null, null, "2021-10-05T20:04:01Z", null, 0, 0, "0900006484dbb0d9"], ["FDA-2018-N-0236-0045", "FDA", "FDA-2018-N-0236", "Ref 16 - 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