ARTICLE SUMMARY:
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in November 2022. Updated November 30.
A roundup of FDA’s actions in November 2022.
| NOVEL DEVICE APPROVALS |
||||||
| Company |
Device |
Date |
Approval Type |
Approval Number |
||
| TriReme Medical |
|
11/04/22 |
Original PMA |
P210039 |
||
| SRS Medical | pathway anti-her-2/neu (4b5) rabbit monoclonal primary antibody |
11/7/22 | Panel-track supplement | P990081 S047 | ||
| PerkinElmer | Eonis SCID-SMA Kit | 11/9/22 | De Novo | DEN200044 | ||
| Ventana Medical Systems | ventana folr1 (folr-2.1) rxdx assay | 11/14/22 | Original PMA | P220006 | ||
| Biosense Webster | qdot micro system | 11/23/22 | Original PMA |
|
||
| One Lambda | SeCore CDx HLA Sequencing System | 11/28/22 | De Novo |
|
||
| BREAKTHROUGH DEVICES |
||||||
| Sponsor |
Device | Clinical Target |
Date |
|||
| Avita Medical | RECELL System | Soft tissue repair, vitiligo | 11/3/22 | |||
| WARNING LETTERS |
||||||
| Company |
Citations |
Posting Date |
Issuing Office |
|||
| None as of 11/30 |
|
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| CLASS 1 RECALLS |
||||||
| Company |
Device |
Date |
Recall Number |
|||
| Insulet |
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010 | 11/15/22 | Z-0154-2023 | |||
| Whele LLC DBA Perch | Mighty Bliss Electric Heating Pads, var. | 11/23/22 | Z-0236-2023 through Z-0238-2023 | |||
| NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS |
||||||
| Test Kit Manufacturer & Commercial Labs |
Date |
|||||
| Nanobiosym Precision Testing Services, The Nano Test for COVID-19 |
11/8/22 | |||||
| Roche Molecular Systems, cobas MPXV for use on the cobas 6800/8800 Systems | 11/15/22 | |||||
| ANP Technologies, NIDS COVID-19 Antigen Home Test | 11/17/22 | |||||
| Beijing Hotgen Biotech, Hotgen COVID-19 Antigen Home Test | 11/17/22 | |||||
| Premier Medical Laboratory Services, Diversified Medical Healthcare SARS-CoV-2 Assay | 11/18/22 | |||||
| Lucira Health, Lucira COVID-19 & Flu Test | 11/22/22 | |||||
