English
KoreanICMC NEWS & LIBRARY
ICMC (International Certification Management Center Co., Ltd.)
-
ICMC NEWS & LIBRARY
-
Medical Devices FDA
icmcert@naver.com
+82-2-851-3111
Medical Devices FDA
[FDA] 의료기기 12.21~12.23 긴급사용승인 현황
- Admin Hits:682
- 2020-12-24 20:05:00
December 23, 2020
-New Emergency Use Authorizations
Solana SARS-CoV-2 Assay (Quidel Corporation)
Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test (Quanterix Corporation)
-Updated Emergency Use Authorizations
Xpert Omni SARS-CoV-2 (Cepheid)
BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) (BioFire Diagnostics, LLC)
EmpowerDX At-Home COVID-19 PCR Test Kit (Clinical Enterprise, Inc.)
Ellume COVID-19 Home Test (Ellume Limited)
Alinity m SARS-CoV-2 assay (Abbott Molecular Inc.)
Supplies of Medical Devices for COVID-19: Frequently Asked Questions
Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
Medical Device Types to Help Determine Section 506J Notification Obligations (Updated)
Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs on Viral Transport Media During COVID-19 (Updated)
Class I Recall: Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy- Borst Side-Arm Introducers Due to Separation in Device
-Recently Approved Devices:
MiniMed 770G System - P160017/S076
December 22, 2020
-Re-issued Emergency Use Authorizations
RightSign COVID-19 IgG/IgM Rapid Test Cassette (Hangzhou Biotest Biotech Co., Ltd.)
-Updated Emergency Use Authorizations
QuickVue SARS Antigen Test (Quidel Corporation)
Verily COVID-19 RT-PCR Test (Verily Life Sciences)
TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC)
Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
-FAQs on Viral Transport Media During COVID-19 (Updated)
-Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers (Revised) - Guidance for Industry and Food and Drug Administration Staff
-Presentation and Transcript posted for Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - December 16, 2020
December 21, 2020
-New Emergency Use Authorizations
QuickVue SARS Antigen Test (Quidel Corporation)
ADVIA Centaur IL6 assay (Siemens Healthcare Diagnostics Inc.)
SCONE
-Updated Emergency Use Authorizations
Appendix A: Authorized Surgical Masks
출처 : https://www.fda.gov/medical-devices/news-events-medical-devices/cdrhnew-news-and-updates
-New Emergency Use Authorizations
Solana SARS-CoV-2 Assay (Quidel Corporation)
Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test (Quanterix Corporation)
-Updated Emergency Use Authorizations
Xpert Omni SARS-CoV-2 (Cepheid)
BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) (BioFire Diagnostics, LLC)
EmpowerDX At-Home COVID-19 PCR Test Kit (Clinical Enterprise, Inc.)
Ellume COVID-19 Home Test (Ellume Limited)
Alinity m SARS-CoV-2 assay (Abbott Molecular Inc.)
Supplies of Medical Devices for COVID-19: Frequently Asked Questions
Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
Medical Device Types to Help Determine Section 506J Notification Obligations (Updated)
Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs on Viral Transport Media During COVID-19 (Updated)
Class I Recall: Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy- Borst Side-Arm Introducers Due to Separation in Device
-Recently Approved Devices:
MiniMed 770G System - P160017/S076
December 22, 2020
-Re-issued Emergency Use Authorizations
RightSign COVID-19 IgG/IgM Rapid Test Cassette (Hangzhou Biotest Biotech Co., Ltd.)
-Updated Emergency Use Authorizations
QuickVue SARS Antigen Test (Quidel Corporation)
Verily COVID-19 RT-PCR Test (Verily Life Sciences)
TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC)
Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
-FAQs on Viral Transport Media During COVID-19 (Updated)
-Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers (Revised) - Guidance for Industry and Food and Drug Administration Staff
-Presentation and Transcript posted for Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - December 16, 2020
December 21, 2020
-New Emergency Use Authorizations
QuickVue SARS Antigen Test (Quidel Corporation)
ADVIA Centaur IL6 assay (Siemens Healthcare Diagnostics Inc.)
SCONE
-Updated Emergency Use Authorizations
Appendix A: Authorized Surgical Masks
출처 : https://www.fda.gov/medical-devices/news-events-medical-devices/cdrhnew-news-and-updates
SNS sharing
TOP
- Company : ICMC (International Certification Management Center Co., Ltd.)
- CEO : Bong Ju Kim
- Address: 16 Digital-ro 32-ga-gil, Guro-gu, Seoul (Guro-dong) Partner Tower 2nd Room 1001.
- TEL : +82-2-851-3111
- FAX : +82-2-2028-3115
- BIZ NO : 214-88-14891
- EMAIL : icmcert@naver.com
10004 certified- 27701 Certified
- Copyright(c) ICMC International Certification Management Center. All Rights Reserved.
