Removal Lists of Tests that Should No Longer Be Used andor ... | 合法醫療器材資訊網

March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency[1] and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)[2]. The guidances outline the FDAs general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDAs recommendations for:

Developing a transition implementation plan, Submitting a marketing submission, and Taking other actions with respect to these devices.

The FDA encourages stakeholders to review the two final guidances, attend the w...

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Removal Lists of Tests that Should No Longer Be Used andor ... | 合法醫療器材資訊網

COVID | 合法醫療器材資訊網

2020年12月30日 — The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. Since the start of the pandemic, ... Read More

Coronavirus (COVID | 合法醫療器材資訊網

2020年11月17日 — The FDA issued an emergency use authorization for the first COVID-19 diagnostic test that allows for self-collection and testing at home and ... Read More

In Vitro Diagnostics EUAs | 合法醫療器材資訊網

7 天前 — Molecular SARS-CoV-2 Diagnostic Tests for COVID-19 that have been ... With granting of the De Novo for the BioFire RP2.1, the FDA revoked the EUA for this ... 02/03/2021, DiaCarta, Inc, QuantiVirus SARS-CoV-2 Test kit Read More

Notifications and Emergency Use Authorizations | 合法醫療器材資訊網

Q: What in vitro diagnostic tests for COVID-19 have been issued an ... Q: What commercial manufacturers are distributing diagnostic test kits under the policy ... Read More

EUA Authorized Serology Test Performance | 合法醫療器材資訊網

2021年5月25日 — This limits the test's effectiveness for diagnosing current COVID-19 and is one reason ... Test: BioCheck SARS-CoV-2 IgG Antibody Test Kit Read More

Coronavirus (COVID | 合法醫療器材資訊網

2020年12月15日 — The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive ... Read More

Lucira™ COVID-19 All-In | 合法醫療器材資訊網

The Lucira COVID-19 All-In-One Test Kit is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is authorized ... Read More

Taiwan FDA approves imports of COVID | 合法醫療器材資訊網

2021年6月12日 — Taipei, June 12 (CNA) Imports of two types of COVID-19 home test kits to Taiwan have been approved, the Food and Drug Administration ... Read More

COVID home test kits to go on sale in Taiwan next week | 合法醫療器材資訊網

2021年6月19日 — Taipei, June 19 (CNA) COVID-19 home test kits will become available in stores across Taiwan next week, the Food and Drug Administration ... Read More

相關資訊整理

Removal Lists of Tests that Should No Longer Be Used andor ... | 合法醫療器材資訊網

Removal Lists of Tests that Should No Longer Be Used andor ... | 合法醫療器材資訊網

COVID | 合法醫療器材資訊網

Coronavirus (COVID | 合法醫療器材資訊網

In Vitro Diagnostics EUAs | 合法醫療器材資訊網

Notifications and Emergency Use Authorizations | 合法醫療器材資訊網

EUA Authorized Serology Test Performance | 合法醫療器材資訊網

Coronavirus (COVID | 合法醫療器材資訊網

Lucira™ COVID-19 All-In | 合法醫療器材資訊網

Taiwan FDA approves imports of COVID | 合法醫療器材資訊網

COVID home test kits to go on sale in Taiwan next week | 合法醫療器材資訊網

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