FDA Output November 2022

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ARTICLE SUMMARY:

Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in November 2022. Updated November 28.

A roundup of FDA’s actions in November 2022.

NOVEL DEVICE APPROVALS

Company

Device

Date

Approval Type

Approval Number

TriReme Medical

  hocolate touch paclitaxel drug-coated pta balloon

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
  P210027

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 11/28


   

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
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