FDA Update – January 17, 2025 FDA Releases Draft Guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency The FDA has issued a new draft guidance to help developers validate diagnostic tests (IVDs) for emerging pathogens during public health emergencies. This guidance aims to ensure that
FDA Update December 6, 2024 COVID Public Health Emergency Exemption from Fees to Expire FDA Reminds OTC Hand Sanitizer Manufacturers of OMUFA Facility Fees for FY 2025 FDA is reminding companies who registered with the agency solely to manufacture hand sanitizer during the COVID-19 public health emergency that they are subject to fiscal year (FY)
As the COVID-19 Crisis Settles Begins to Settle into a More “Endemic” State, FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types We were expecting this change – here it is. The U.S. Food and Drug Administration updated its COVID-19 test policy to ensure continued access to tests
We knew this would be happening at some time and it appears that it will next month – the EUA will end. As the COVID-19 Crisis Returns to Pre-Pandemic Levels… FDA Intends to Withdraw Final Guidance: Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices – Questions
The FDA has been deciding on how to work the ISO 13465-2016 into the QSR for many years. The covid situation has put this process on hold, but it is appears it is now back on the agenda. These changes are supposed to make the FDA QSR more in line with the ISO standard. The
Sanitation Tunnels for COVID-19 Disinfection Not Encouraged by FDA These times have lent themselves to some crazy Covid prevention devices and treatment. Here is one that the FDA feels should not be used. The U.S. Food and Drug Administration issued a guidance for industry and investigators titled “COVID-19 Public Health Emergency: Policy on COVID-19-Related Sanitation
As the COVID-19 variants surface and spread we are learning that testing methods may be affected and may in fact become ineffective. The FDA is in a race to keep up with the changes… SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests The SARS-CoV-2 virus has mutated over time, resulting in genetic variation in the population
Recently, the FDA put out this update on the various government agencies (FDA/NIOSH/OSHA) and their responsibilities related to Covid 19. With all the confusion concerning respiratory and surgical masks we felt it was important enough to post it. COVID 19 has proven that we need to take respiratory protection very seriously. Whether it be in
The U.S. Food and Drug Administration has updated their discontinued medical devices list during the COVID-19 Public Health Emergency. The recently added items include gastroenterostomy tubes, gastrointestinal tubes, and accessories. Specific items recently added to the discontinuance list are manufactured by Bard Access Systems: 20F PULL Ponsky 20F PUSH Ponsky Bolus Feeding Tube Button Gastrostomy
FDA Issues Policies to Guide COVID-19 Treatment Development On February 22, 2021 the FDA released two guidances regarding the development of COVID-19 drugs. The first guidance specifically deals with the development of monoclonal antibody products, while the second guidance is focused on drugs that treat or prevent COVID-19. These guidances contain non-binding recommendations for sponsors
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