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
FDA Update February 10, 2022 Warning – FDA could be knocking on your door! The FDA Restarts Routine Domestic Surveillance Inspections With the decline of Covid-19 cases across the country, the FDA has decided to re-start their routine domestic surveillance inspections in the US. The FDA will also resume their foreign surveillance inspections provided that
FDA Update February 8, 2022 With False Results and Possible Dangerous Sampling Methods, the FDA Advises Consumers to Not Use E25Bio COVID-19 Testing Kits With all the rush to get covid tests on the market some companies always try to circumvent the FDA approval process. Here is one case where the FDA has caught
Visible Particulates Can Harm Patients – FDA Announces a More Holistic Screening Approach for Safety The U.S. Food and Drug Administration is announcing the draft guidance for industry entitled “Inspection of Injectable Products for Visible Particulates.” Visible particulates in injectable products can harm patients. This draft guidance addresses the development and implementation of a holistic,
New FDA Draft Guidance Clarifies the Terms Device vs. Counterfeit Device It is apparent that there has been some problem with the FDA addressing devices as misbranded and/or adulterated when there was not a definition of a “counterfeit” device. So the FDA had to come up with a definition of a counterfeit device and is
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
FDA Proposes Changes to Agricultural Water Requirements in the Produce Safety Rule In an effort to address and eradicate potential contamination in regard to pre-harvest agricultural water the U.S. Food and Drug Administration published a proposed rule that would revise subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule to change certain pre-harvest
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
We were always curious about how the FDA classified blood lancet devices as 510(k) exempt. Well, now the FDA has finally decided that blood lancets do require a 510(k). The FDA has four types of lancets, three are single patient and require a 510(k) and one intended for multiple use that would require a PMA.
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