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withdrawn,object_id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-2021-N-0341-0005,FDA,FDA-2021-N-0341,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:29:28Z,2021-28362,0,0,0900006484f005d4
FDA-2015-N-1837-0011,FDA,FDA-2015-N-1837,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:29:00Z,2021-28362,0,0,0900006484f005d5
FDA-2021-V-1357-0002,FDA,FDA-2021-V-1357,Acknowledgment Letter from FDA DMS to Sober Sound,Other,Acknowledgement Letter/Receipt,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T13:49:09Z,,0,0,0900006484f009ff
FDA-2021-V-1293-0003,FDA,FDA-2021-V-1293,Variance Approval Letter from FDA CDRH to Supercalibrations,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:38:29Z,,0,0,0900006484f013f6
FDA-2021-V-1359-0002,FDA,FDA-2021-V-1359,Acknowledgment Letter from FDA DMS to Washington University,Other,Acknowledgement Letter/Receipt,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:47:06Z,,0,0,0900006484f0126d
FDA-2021-V-1278-0003,FDA,FDA-2021-V-1278,Variance Approval Letter from FDA CDRH to Tranquility Zone LLP,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:22:59Z,,0,0,0900006484f01397
FDA-2020-N-1307-0024,FDA,FDA-2020-N-1307,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:32:10Z,2021-28362,0,0,0900006484f005cf
FDA-2021-N-0356-0003,FDA,FDA-2021-N-0356,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:31:08Z,2021-28362,0,0,0900006484f005d1
FDA-2021-V-1267-0003,FDA,FDA-2021-V-1267,Variance Approval Letter from FDA CDRH to Garrett Mcgrath,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:16:17Z,,0,0,0900006484f01300
FDA-2021-V-1276-0003,FDA,FDA-2021-V-1276,Variance Approval Letter from FDA CDRH to Custom Audio and Lighting,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:17:33Z,,0,0,0900006484f01341
FDA-2021-V-1282-0003,FDA,FDA-2021-V-1282,Variance Approval Letter from FDA CDRH to Systems Design and Integration Inc,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:26:45Z,,0,0,0900006484f0139e
FDA-2021-V-1359-0001,FDA,FDA-2021-V-1359,Variance Application from Washington University,Other,Application for Variance (VAR),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:45:51Z,,0,0,0900006484f0126b
FDA-2021-V-1264-0003,FDA,FDA-2021-V-1264,Variance Approval Letter from FDA CDRH to Hendo Studios,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:34:29Z,,0,0,0900006484f0133d
FDA-2018-N-1857-0012,FDA,FDA-2018-N-1857,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:30:05Z,2021-28362,0,0,0900006484f005d3
FDA-2011-D-0147-0039,FDA,FDA-2011-D-0147,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:30:37Z,2021-28362,0,0,0900006484f005d2
FDA-2021-V-1303-0003,FDA,FDA-2021-V-1303,Variance Approval Letter from FDA CDRH to DTX Digital Theater Experts,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:41:38Z,,0,0,0900006484f013fb
FDA-2021-V-1304-0003,FDA,FDA-2021-V-1304,Variance Approval Letter from FDA CDRH to Lunarhive LLC,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:31:10Z,,0,0,0900006484f013b5
FDA-2021-V-1307-0003,FDA,FDA-2021-V-1307,Variance Approval Letter from FDA CDRH to The Experts,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:44:30Z,,0,0,0900006484f013fe
FDA-2021-V-1291-0003,FDA,FDA-2021-V-1291,Variance Approval Letter from FDA CDRH to Automated Living Inc,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:34:23Z,,0,0,0900006484f013da
FDA-2021-V-1270-0003,FDA,FDA-2021-V-1270,Variance Approval Letter from FDA CDRH to Executive Electronics,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:42:43Z,,0,0,0900006484f013fa
FDA-2012-N-0536-0016,FDA,FDA-2012-N-0536,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T14:25:40Z,2021-28362,0,0,0900006484f003cd
FDA-2021-V-1360-0001,FDA,FDA-2021-V-1360,Variance Application from William Potter,Other,Application for Variance (VAR),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:47:19Z,,0,0,0900006484f012f7
FDA-2014-N-1048-0011,FDA,FDA-2014-N-1048,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2022-08-24T14:18:15Z,2021-28362,0,0,0900006484f005d0
FDA-2021-V-1357-0001,FDA,FDA-2021-V-1357,Variance Application from Sober Sound,Other,Application for Variance (VAR),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T13:39:38Z,,0,0,0900006484f009f9
FDA-2021-V-1295-0003,FDA,FDA-2021-V-1295,Variance Approval Letter from FDA CDRH to Travel Marquette,Other,Approval for Variance (VRA),2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T18:12:01Z,,0,0,0900006484f019ce
FDA-2021-V-1360-0002,FDA,FDA-2021-V-1360,Acknowledgment Letter from FDA DMS to William Potter,Other,Acknowledgement Letter/Receipt,2021-12-30T05:00:00Z,2021,12,2021-12-30T05:00:00Z,,2021-12-30T15:49:47Z,,0,0,0900006484f012f9
FDA-2018-C-4117-0005,FDA,FDA-2018-C-4117,"Listing of Color Additives Exempt
From Certification; Butterfly Pea
Flower Extract; Confirmation of
Effective Date",Rule,Confirmation of Effective Date,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2024-02-08T19:39:46Z,2021-28158,0,0,0900006484effc3e
FDA-2018-C-4117-0004,FDA,FDA-2018-C-4117,"Listing of Color Additives Exempt
From Certification; Butterfly Pea
Flower Extract; Confirmation of
Effective Date",Rule,Final Rule,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2024-02-08T19:39:30Z,2021-28159,0,0,0900006484effabc
FDA-2013-N-1529-0026,FDA,FDA-2013-N-1529,"Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reclassification
Petitions for Medical Devices",Notice,30 Day Proposed Information Collection,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,2022-01-29T04:59:59Z,2021-12-29T17:25:49Z,2021-28299,0,0,0900006484effa24
FDA-2021-V-1257-0003,FDA,FDA-2021-V-1257,Variance Approval Letter from FDA CDRH to Nick Glover,Other,Approval for Variance (VRA),2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T20:54:12Z,,0,0,0900006484f009a5
FDA-2021-F-1157-0001,FDA,FDA-2021-F-1157,"Lallemand Inc.; Filing of Food Additive
Petition",Proposed Rule,Petition,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2024-11-12T23:36:20Z,2021-28162,1,0,0900006484effb97
FDA-2021-N-0858-0001,FDA,FDA-2021-N-0858,"Medical Devices; Gastroenterology-
Urology Devices; Classification of the
Transcutaneous Electrical Continence
Device",Rule,Final Rule,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T17:27:03Z,2021-28163,0,0,0900006484effb9a
FDA-2021-N-0874-0052,FDA,FDA-2021-N-0874,Intarcia Letter to Office of the Commissioner,Other,Letter(s),2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T13:57:57Z,,0,0,0900006484f0006f
FDA-2021-N-0573-0001,FDA,FDA-2021-N-0573,"Medical Devices; Neurological
Devices; Classification of the
Diagnostic Neurosurgical Microscope
Filter",Rule,Final Rule,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T17:27:59Z,2021-28160,0,0,0900006484effbf4
FDA-2021-V-1355-0001,FDA,FDA-2021-V-1355,Variance Application from Sean Chaney,Other,Application for Variance (VAR),2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T14:41:36Z,,0,0,0900006484f00033
FDA-2021-V-1256-0003,FDA,FDA-2021-V-1256,Variance Approval Letter from FDA CDRH to Jonathan Bixler,Other,Approval for Variance (VRA),2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T20:59:18Z,,0,0,0900006484f009fb
FDA-2013-N-1529-0027,FDA,FDA-2013-N-1529,"Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reclassification
Petitions for Medical Devices",Notice,30 Day Proposed Information Collection,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,2022-01-29T04:59:59Z,2022-01-29T02:00:36Z,2021-28305,0,0,0900006484effb4a
FDA-2021-V-1355-0002,FDA,FDA-2021-V-1355,Acknowledgment Letter from FDA DMS to Sean Chaney,Other,Acknowledgement Letter/Receipt,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T14:38:33Z,,0,0,0900006484f00069
FDA-2021-P-0895-0003,FDA,FDA-2021-P-0895,Petition Response from FDA CDER to Eagle Pharmaceuticals,Other,Agency Response,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T13:27:34Z,,0,0,0900006484f0002f
FDA-2021-N-0855-0001,FDA,FDA-2021-N-0855,"Medical Devices; Neurological
Devices; Classification of the
Cerebrospinal Fluid Shunt System",Rule,Final Rule,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T17:26:25Z,2021-28157,0,0,0900006484effaf3
FDA-2012-P-1189-0015,FDA,FDA-2012-P-1189,Canned Tuna Deviating From the Standard of Identity; Amendment of Temporary Marketing Permits,Notice,General Notice,2021-12-28T05:00:00Z,2021,12,2021-12-28T05:00:00Z,,2021-12-28T17:40:01Z,2021-28164,0,0,0900006484efed05
FDA-2021-N-0917-0001,FDA,FDA-2021-N-0917,"Medical Devices; Anesthesiology
Devices; Classification of the
Retrograde Intubation Device",Rule,Final Rule,2021-12-28T05:00:00Z,2021,12,2021-12-28T05:00:00Z,,2021-12-28T17:42:04Z,2021-28166,0,0,0900006484efed3f
FDA-2021-V-1187-0003,FDA,FDA-2021-V-1187,Variance Approval Letter from FDA CDRH to RK Lighting LLC,Other,Approval for Variance (VRA),2021-12-28T05:00:00Z,2021,12,2021-12-28T05:00:00Z,,2021-12-28T17:21:26Z,,0,0,0900006484efec8f
FDA-2021-V-1290-0003,FDA,FDA-2021-V-1290,Variance Approval Letter from FDA CDRH to Sergio Rangel,Other,Approval for Variance (VRA),2021-12-28T05:00:00Z,2021,12,2021-12-28T05:00:00Z,,2021-12-28T17:35:41Z,,0,0,0900006484eff191
FDA-2021-N-1252-0001,FDA,FDA-2021-N-1252,"Panray Corp. Sub Ormont Drug and Chemical Co., Inc., et al.; Proposal To Withdraw Approval of Three New Drug Applications; Opportunity for a Hearing",Notice,Withdrawal,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,2022-02-26T04:59:59Z,2021-12-27T14:24:54Z,2021-27946,0,0,0900006484efd6cc
FDA-2015-N-3534-0302,FDA,FDA-2015-N-3534,Nomination from College Pharmacy,Other,Nomination,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T15:34:37Z,,0,0,0900006484ed3d53
FDA-2021-D-0367-0002,FDA,FDA-2021-D-0367,Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24) Draft Compliance Policy Guide Guidance for FDA Staff,Other,Guidance,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,2022-04-15T03:59:59Z,2025-07-16T09:00:27Z,,1,0,0900006484efdb70
FDA-2021-V-1220-0003,FDA,FDA-2021-V-1220,Variance Approval from FDA CDRH to Na’cho Production and Design LLC,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:04:08Z,,0,0,0900006484efd942
FDA-2021-V-1315-0003,FDA,FDA-2021-V-1315,Variance Approval from FDA CDRH to Tobin Tanner Designs,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:55:49Z,,0,0,0900006484efd980
FDA-2021-V-1235-0003,FDA,FDA-2021-V-1235,Variance Approval from FDA CDRH to Christopher Kent,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:32:03Z,,0,0,0900006484efd947
FDA-2019-D-2330-0035,FDA,FDA-2019-D-2330,Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers Guidance for Industry,Other,Guidance,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2024-11-12T23:35:32Z,,1,0,0900006484efda35
FDA-2021-D-0367-0001,FDA,FDA-2021-D-0367,"Compliance Policy Guide Sec. 540.525
Scombrotoxin (Histamine)-Forming
Fish and Fishery Products—
Decomposition and Histamine;
Availability",Notice,Notice of Availability,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,2022-02-26T04:59:59Z,2022-03-15T15:47:30Z,2021-28053,0,0,0900006484efd850
FDA-2021-P-1354-0001,FDA,FDA-2021-P-1354,Citizen Petition from Cardinal Health Regulatory Sciences,Other,Citizen Petition,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2022-04-13T14:35:43Z,,0,0,0900006484efd9a0
FDA-2021-V-1259-0003,FDA,FDA-2021-V-1259,Variance Approval from FDA CDRH to A Bright Idea,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:52:03Z,,0,0,0900006484efd97e
FDA-2021-P-1354-0004,FDA,FDA-2021-P-1354,Orange Book August 2021 Changes List re Citizen Petition from Cardinal Health Regulatory Sciences,Supporting & Related Material,Background Material,2021-12-27T05:00:00Z,2021,12,,,2021-12-27T18:24:41Z,,0,0,0900006484efdb6f
FDA-2021-V-1237-0003,FDA,FDA-2021-V-1237,Variance Approval from FDA CDRH to Chris Andrews,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:37:14Z,,0,0,0900006484efd21a
FDA-2019-D-2330-0034,FDA,FDA-2019-D-2330,Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers; Guidance for Industry; Availability,Notice,Notice of Availability,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T14:29:13Z,2021-28051,0,0,0900006484efd807
FDA-2021-V-0905-0003,FDA,FDA-2021-V-0905,"Variance Approval from FDA CDRH to Orange Coast College Planetarium, Orange Coast College",Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T18:44:38Z,,0,0,0900006484efe147
FDA-2021-P-1354-0002,FDA,FDA-2021-P-1354,Acknowledgment Letter from FDA DMS to Cardinal Health Regulatory Sciences,Other,Acknowledgement Letter/Receipt,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T18:24:22Z,,0,0,0900006484efdb74
FDA-2021-P-1354-0003,FDA,FDA-2021-P-1354,Attachment 1 Orange Book - Therapeutic Equiv to TOTECT re Citizen Petition from Cardinal Health Regulatory Sciences,Supporting & Related Material,Background Material,2021-12-27T05:00:00Z,2021,12,,,2021-12-27T18:24:34Z,,0,0,0900006484efdb6e
FDA-2020-D-1118-0007,FDA,FDA-2020-D-1118,"Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)
Guidance for Industry and Food and Drug Administration Staff",Other,Guidance,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2024-11-12T23:35:29Z,,1,0,0900006484efdb6c
FDA-2021-V-1242-0003,FDA,FDA-2021-V-1242,Variance Approval from FDA CDRH to BIOPTIMIZERS USA INC,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:42:09Z,,0,0,0900006484efd21c
FDA-2020-D-1118-0006,FDA,FDA-2020-D-1118,"Non-Clinical and Clinical Investigation
of Devices Used for the Treatment of
Benign Prostatic Hyperplasia;
Guidance for Industry and Food and
Drug Administration Staff; Availability",Notice,Notice of Availability,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T14:34:07Z,2021-27919,0,0,0900006484efd897
FDA-2015-N-3469-0352,FDA,FDA-2015-N-3469,Nomination from OUTSOURCING FACILITIES ASSOCIATION,Other,Nomination,2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T14:59:56Z,,0,0,0900006484ee8292
FDA-2021-V-1324-0003,FDA,FDA-2021-V-1324,Variance Approval from FDA CDRH to AVIO Inc,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:46:01Z,,0,0,0900006484efd949
FDA-2021-H-1342-0001,FDA,FDA-2021-H-1342,Complaint,Other,Complaint,2021-12-27T05:00:00Z,2021,12,2021-12-28T05:00:00Z,,2021-12-28T12:46:41Z,,0,0,0900006484efe26d
FDA-2021-V-1218-0003,FDA,FDA-2021-V-1218,Variance Approval from FDA CDRH to NPI Audio Visual Solutions,Other,Approval for Variance (VRA),2021-12-27T05:00:00Z,2021,12,2021-12-27T05:00:00Z,,2021-12-27T13:23:37Z,,0,0,0900006484efd945
FDA-2021-D-0980-0002,FDA,FDA-2021-D-0980,Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,2022-03-25T03:59:59Z,2023-11-16T22:21:11Z,2021-27812,0,0,0900006484ee208a
FDA-2021-D-1128-0002,FDA,FDA-2021-D-1128,"Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Guidance for Industry, Investigators, and Other Stakeholders; DRAFT GUIDANCE",Other,Guidance,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,2022-03-24T03:59:59Z,2023-12-22T15:31:03Z,,0,0,0900006484ee7ccb
FDA-2018-P-4664-0004,FDA,FDA-2018-P-4664,Withdrawal from Fresenius Kabi USA LLC,Other,Withdrawal,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T16:38:00Z,,0,0,0900006484ed3736
FDA-2021-V-1345-0002,FDA,FDA-2021-V-1345,Acknowledgement Letter from FDA DMS to Vincent Lighting Systems Company,Other,Acknowledgement Letter/Receipt,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T15:48:58Z,,0,0,0900006484ee28af
FDA-2021-D-0996-0002,FDA,FDA-2021-D-0996,Technical Considerations for Medical Devices With Physiologic Closed-Loop Control Technology; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T14:34:15Z,2021-27825,0,0,0900006484ee7f1d
FDA-2021-V-1344-0002,FDA,FDA-2021-V-1344,Acknowledgement Letter from FDA DMS to Rockstar Production Events LLC,Other,Acknowledgement Letter/Receipt,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T15:44:36Z,,0,0,0900006484ee3970
FDA-2021-V-1350-0003,FDA,FDA-2021-V-1350,"Attachment 1 RE Variance Application from Optoma Technology, Inc",Supporting & Related Material,Background Material,2021-12-23T05:00:00Z,2021,12,,,2021-12-23T13:00:26Z,,0,0,0900006484ee70d6
FDA-2021-P-1347-0002,FDA,FDA-2021-P-1347,Acknowledgment Letter from FDA DMS to Americans for Responsible Technology,Other,Acknowledgement Letter/Receipt,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-27T14:00:51Z,,0,0,0900006484ee57bc
FDA-2019-D-5606-0004,FDA,FDA-2019-D-5606,"Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use- Premarket Notification (510(k))
Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T14:01:37Z,2021-27823,0,0,0900006484ee7f15
FDA-2021-D-1031-0007,FDA,FDA-2021-D-1031,Request for Extension from International Society for Pharmaceutical Engineering (ISPE),Other,Request for Extension,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T18:01:27Z,,0,0,0900006484ed0634
FDA-2021-D-1149-0001,FDA,FDA-2021-D-1149,Transition Plan for Medical Devices Issued Emergency Use Authorizations During the Coronavirus Disease 2019 Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff;  Availability; Agency Information Collection Activities; Proposed Collection; Comment Request,Notice,Notice of Availability,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2022-04-02T23:44:43Z,2021-27891,0,0,0900006484ee7e2c
FDA-2019-P-2687-0004,FDA,FDA-2019-P-2687,Withdrawal from AuroMedics Pharma LLC on behalf of Aurobindo Pharma Ltd.,Other,Withdrawal,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T16:45:27Z,,0,0,0900006484ec86ae
FDA-2020-D-1118-0005,FDA,FDA-2020-D-1118,Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH); Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-27T16:53:22Z,,0,0,0900006484ee91b6
FDA-2019-D-5606-0005,FDA,FDA-2019-D-5606,Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2024-11-07T00:35:31Z,,1,0,0900006484ee7ccd
FDA-2021-P-1347-0001,FDA,FDA-2021-P-1347,Citizen Petition from Americans for Responsible Technology,Other,Citizen Petition,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2025-03-12T01:00:53Z,,1,0,0900006484ee5772
FDA-2021-D-1118-0002,FDA,FDA-2021-D-1118,Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,2022-03-24T03:59:59Z,2023-03-24T19:22:26Z,,0,0,0900006484ee7cc8
FDA-2018-N-4206-0004,FDA,FDA-2018-N-4206,Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification,Notice,60 Day Proposed Information Collection,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,2022-02-23T04:59:59Z,2022-02-23T02:00:25Z,2021-27889,0,0,0900006484ee7e8c
FDA-2021-D-1118-0001,FDA,FDA-2021-D-1118,Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request,Notice,Notice of Availability,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2022-02-02T02:00:22Z,2021-27892,0,0,0900006484ee7e8e
FDA-2021-D-1128-0001,FDA,FDA-2021-D-1128,"Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for
Industry, Investigators, and Other Stakeholders; Availability",Notice,Notice of Availability,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T14:24:00Z,2021-27894,0,0,0900006484ee7ee5
FDA-2021-N-0310-0012,FDA,FDA-2021-N-0310,Reference 3 - Proposed Regulatory Impact Analysis,Supporting & Related Material,Background Material,2021-12-23T05:00:00Z,2021,12,,,2021-12-23T15:58:32Z,,0,0,0900006484ee94a5
FDA-2021-V-1345-0001,FDA,FDA-2021-V-1345,Variance Application from Vincent Lighting Systems Company,Other,Application for Variance (VAR),2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T15:48:48Z,,0,0,0900006484ee243a
FDA-2021-V-1344-0001,FDA,FDA-2021-V-1344,Variance Application from Rockstar Production Events LLC,Other,Application for Variance (VAR),2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T15:44:20Z,,0,0,0900006484ee396e
FDA-2021-D-1149-0002,FDA,FDA-2021-D-1149,Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,2022-03-24T03:59:59Z,2023-03-24T17:56:10Z,,0,0,0900006484ee7574
FDA-2018-D-1774-0039,FDA,FDA-2018-D-1774,Request for Hearing from Prime Policy Group,Other,Request for Hearing,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T16:32:59Z,,0,0,0900006484ed7724
FDA-2014-P-1038-0006,FDA,FDA-2014-P-1038,Withdrawal From Lachman Consultant Services Inc,Other,Withdrawal,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T16:23:30Z,,0,0,0900006484ed71ed
FDA-2020-P-2003-0458,FDA,FDA-2020-P-2003,Memorandum from FDA CFSAN on Health and Chemicals Coalition Meeting,Other,Memorandum,2021-12-23T05:00:00Z,2021,12,2021-12-23T05:00:00Z,,2021-12-23T18:54:31Z,,0,0,0900006484ee98a9
FDA-1997-S-0006-1735,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to Market America,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:19:52Z,,0,0,0900006484eaf935
FDA-1997-S-0006-1789,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to VIVRI USA LLC,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:20:54Z,,0,0,0900006484eaf9f4
FDA-1997-S-0006-1740,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to USANA Health Sciences Inc,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:19:57Z,,0,0,0900006484eaf946
FDA-1997-S-0006-1797,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to BioSchwartz,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:21:03Z,,0,0,0900006484ece601
FDA-1997-S-0006-1752,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to Nutrallion,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:20:11Z,,0,0,0900006484eaf99d
FDA-1997-S-0006-1790,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to Corporation Genacol Canada Inc.,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:20:55Z,,0,0,0900006484eaf9f6
FDA-1997-S-0006-1731,FDA,FDA-1997-S-0006,Courtesy letter and related material from CFSAN to Greeniche Natural Health Inc.,Other,Letter(s),2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:19:47Z,,0,0,0900006484eaf926