FDA Output December 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 December 2022. Updated December 31.

A roundup of FDA’s actions in December 2022.

NOVEL DEVICE APPROVALS

Company

Device

Date

Approval Type

Approval Number

Endomagnetics magtracetm and sentimag(r) magnetic locatization system 12/6/2 Panel-track supplement P160053 S002
Resolution Bioscience resolution ctdx first 12/12/22 Original PMA P210040
Abbott Medical  
   
flexability ablation catheter, sensor enabled 12/14/22 Panel-track supplement P110016 S080
  Tornier
Tornier Pyrocarbon Humeral Head 12/16/22 De Novo DEN220012
Foundation Medicine foundationone liquid cdx (f1lcdx) 12/22/22 Panel-track supplement P190032 S004
Nanovi BioXmark 12/23/22 De Novo DEN220017

BREAKTHROUGH DEVICES

Sponsor

Device

Clinical Target

Date

Click Therapeutics CT-132 digital therapeutic Episodic migraine 12/19/22

WARNING LETTERS

Company

Citations

Posting Date

Issuing Office

Empowered Diagnostics

Premarket (COVID-19)

12/27/22 OHT7: Office of In Vitro Diagnostics
RoyalVibe Health Premarket 12/27/22 OHT 4: Office of Surgery and Infection
Control Devices

CLASS 1 RECALLS

Company

Device

Date

Recall Number

Caire
CAIRE Liberator Liquid Oxygen System Unit, var. models 12/1/22 Z- 0336-2023 through Z-0339-2023
Remel Thermo SCIENTIFIC, Sensititre  Gram Negative IVD AST, var.
12/8/22 Z-0327-2023 through Z-0335-2023
Arrow International Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit
12/10/22 Z-0352-2023
Arrow International Arrow MAC Two-Lumen Central Venous Access Kit 12/10/22
  Z-0351-2023
Arrow International Arrow AutoCAT2 Intra-aortic balloon  pumps, var. 12/15/22 Z-0426-2023 through Z-0456-2023

NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS

Test Kit Manufacturer & Commercial Labs

Date

Diazyme Laboratories, Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit
12/6/22
ACON Laboratories, Flowflex COVID-19 Antigen Rapid Test 12/6/22
Life Technologies, TaqPath Monkeypox/Orthopox Virus DNA Kit 12/13/22
OnSiteGene, Hi-Sense COVID-19 Molecular Testing Kit 1.0  12/19/22
CTK Biotech, ImmuView COVID-19 Antigen Home Test  12/20/22
Oceanit Foundry, ASSURE-100 Rapid COVID-19 Home Test 12/22/22
Advin Biotech, Advin COVID-19 Antigen Test @Home 12/22/22
Visby Medical, Visby Medical Respiratory Health Test 12/23/22
BD, VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System 12/23/22
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