FDA Update – January 17, 2025 FDA Releases Draft Guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency The FDA has issued a new draft guidance to help developers validate diagnostic tests (IVDs) for emerging pathogens during public health emergencies.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
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
We want to keep everyone updated on the FDA EUA situation and for which devices they have discontinued the EUAs. We knew that the EUA was only temporary under the emergency COVID situation and now the FDA is starting to cut back on the EUAs as they have more supplies available to the marketplace via
Public Safety Alert: Stricter Guidelines Issued by the FDA for Alcohol-Based Hand Sanitizers Will Go Into Effect for 2022 – Pre-COVID Requirements Will Resume As we progress under the COVID rules that were put into effect as part of the EUA, the FDA is starting to rescind these EUAs as the supply shortages have been
Could this be the start of the FDA rescinding the EUAs? On October 15, 2020, the FDA reissued the EUA for certain filtering face-piece respirators (FFRs) manufactured in China which are not approved by the CDC’s National Institute for Occupational Safety and Health (NIOSH). The agency is reissuing this EUA to authorize only those types
mdi predicated that the FDA would be closing these EUA down as soon as there are enough supply on the market. (https://mdiconsultants.com/life-after-the-eua/) The FDA monitors the 510(k) activity as we as the importing supply. The FDA has also been contacting companies to determine the amount of supply of various devices. This is the history of
Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Health Care Providers As the FDA learns more about what is effective and what isn’t or possibly harmful for the treatment of COVID-19, they make adjustments. Here is an EUA that they issued for a medical device back
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