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MQSA Inspection Information Related to COVID-19
… andards-act-and-program/mqsa-inspection-information-related-covid-19 … The U.S. Food and Drug Administration (FDA) has received inquiries about the impact of COVID-19 on mammography facilities. On March 18, 2020, the …
Actualización sobre el coronavirus (COVID-19): la FDA autoriza la prueba Quidel QuickVue At-Home COVID-19
… ress-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-autoriza-la-prueba-quidel-quickvue-home-covid-19 … English Hoy, la Administración de Alimentos y …
FDA Commissioned Corps Officers on the Front Line of COVID-19 Response
… vents/fda-voices/fda-commissioned-corps-officers-front-line-covid-19-response … By: Stephen M. Hahn, M.D., Commissioner of Food … there will be fewer people with coronavirus disease 2019 (COVID-19), it will allow our first responders and health care …
CDRH Learn
… to the Medical Device User Fee Program: MDUFA V (New 7/19/23) Presentation Printable Slides Transcript MDUFA … of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency Presentation Printable … Transcript 75 12/15/2021 Presentation Transcript 76 COVID-19 01/12/2022 Presentation Transcript 77 COVID-19 …
CDRHNew - News and Updates
… Use Authorization Aptitude Medical Systems Inc.: Metrix COVID-19 Test At-Home OTC COVID-19 Diagnostic Tests (Updated) Class I Recall: …
2022 Safety Communications
… Communication Respiratory Español 08/11/2022 At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False … Gastrointestinal 03/18/2022 Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety …
2022 Medical Device Recalls
… Devices 10/18/22 Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or … Delivery 07/20/22 American Contract Systems Recalls COVID Test Kits Nonsterile and Clean Catch Urine Kits for …
Withdrawn or Expired Guidance
… Administration Staff 12/12/2016 10/17/2022 Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee … Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and …
Highlighting Major Issues Critical to FDA Across Our Diverse Agency After One Year Back
… ownership of cell phones. The combination of the COVID-19 pandemic and the rise of misinformation purveyors on this … we have ADUFA and AGDUFA up for authorization this year. COVID-19 Pandemic I can’t think about the past year without …
MedSun Newsletter: April 2022, Volume 22, Issue 4
… USA Recalls Certain Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and … 15, 2022 The Point of Care (POC) Celltrion DiaTrust COVID-19 Ag Rapid Test is intended to detect the presence of …
FDA’s Continued Commitment to the Safety and Security of Our Laboratories
… inspections as well as at ports of entry throughout the COVID-19 pandemic. Moreover, the FDA’s state-of-the-art laboratory … diseases like HIV, tuberculosis, malaria, and, of course, COVID-19. The laboratory complexes house more than 2,500 …
FDA en español
… reciente Conozca sus opciones de tratamiento contra el COVID-19 El COVID-19, la influenza y el virus respiratorio sincitial …
FDA’s National Center for Toxicological Research Celebrates Half a Century of Cutting-Edge Research
… developed a method to detect the virus that causes COVID-19 in wastewater, yielding important data to support the COVID-19 response. Because individuals shed the virus in …
Remarks by Acting Commissioner Janet Woodcock at Scientific Adventures for Girls - 09/23/2021
… to focus on. For example, today’s discussion is on COVID-19. The FDA plays an important role in that response, which … of data than in our response to the virus that causes COVID-19. It involves a careful balancing of scientific …
Remarks by Dr. Woodcock at the 50th Anniversary Celebration of the FDA's National Center for Toxicological Research - 08/12/2021
… public health emergencies, including, most recently, the COVID-19 pandemic. To give you an example, during the current … in Arkansas to monitor the presence and the extent of the COVID-19 epidemic. The Division of Bioinformatics and …
CDRH Events
… Town Hall Test Development and Validation During the COVID-19 Public Health Emergency 04/18/2023 Webinar Webinar on Guidances on COVID-19 Transition Plans for Medical Devices 04/13/2023 …
FDA’s Technology Modernization Action Plan Accelerates the Path to Enhancing and Promoting “People First” Public Health
… to advance the agency’s mission priorities during the COVID-19 pandemic. The FDA’s Office of Information Management and … In April 2020, we announced our participation in the COVID-19 Evidence Accelerator (EA), an initiative launched by …
CDRH Statements
… Issues Final Guidances to Assist with Transition Plans for COVID-19-Related Medical Devices CDRH Statement on Emergency Use Authorization of Lucira Health’s COVID-19 & Flu Home Test January 2023 FDA Issues Two Warning …
eMDR – Electronic Medical Device Reporting
… (EUA) or following an Enforcement Policy Guidance for a COVID-19-related medical device may find useful the additional … Under Emergency Use Authorization (EUA) or the relevant COVID-19-Related Guidance Document . New reporters who have …
A Culture of Responsibility: Laboratory Safety at the FDA
… on identifying best practices and lessons learned from the COVID-19 pandemic. Stephen M. Hahn, M.D. As a nation, we have made … risk associated with SARS- CoV-2, the virus that causes COVID-19, for our staff and research scientists as they work …
Fulfilling Essential Public Health Needs in 2022
… The U.S. Food and Drug Administration’s response to the COVID-19 pandemic has brought the FDA’s critical public health role … conditions. Emergency Preparedness and Response Third, the COVID-19 pandemic demonstrated the agency’s unique ability to …
FDA’s Technology and Data Modernization in Action in 2022
… ago – including how the world thinks about health. The COVID-19 pandemic accelerated these changes and underscored the … to advance the use of Real-World Data (RWD) to inform the COVID-19 response. In collaboration, ODT and the FDA’s Office …
Legacy Identification Number (NDC/NHRIC): Frequently Asked Questions
… 2021. In May 2021 , in recognition of the challenges the COVID-19 public health emergency presented to the entire health … for many stakeholders to shift priorities as part of the COVID-19 response effort, the FDA extended this policy for …
CDRH 2022 Annual Report
… the report include: CDRH By the Numbers Pandemic Response COVID-19 Mpox MDUFA V Device Innovation Novel Devices Upstream …
Health Fraud Scams
… [ Flickr ] Fraudulent Coronavirus Disease 2019 (COVID-19) Products Tainted Honey-based Products with Hidden Active … vaping products with unproven health claims Health Fraud & COVID-19: What You Need to Know (Podcast) FDA Announces …