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8,221 rows where agency_id = "FDA" 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-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 | Dietary Supplements, Courtesy Letters (Letters of Objection) 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 | Dietary Supplements, Courtesy Letters (Letters of Objection) 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 | Dietary Supplements, Courtesy Letters (Letters of Objection) 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 | Dietary Supplements, Courtesy Letters (Letters of Objection) 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 | Dietary Supplements, Courtesy Letters (Letters of Objection) 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 | Dietary Supplements, Courtesy Letters (Letters of Objection) 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 | Dietary Supplements, Courtesy Letters (Letters of Objection) 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 |
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