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02 May

FDA Update: The FDA Continues to Streamline their Process As They Announce Minor Updates to Refuse to Accept Policy for 510(k)s – Final Guidance Helps to Clarify What Is Acceptable to the FDA

On April 25, 2022 the U.S. Food and Drug Administration (FDA) updated the 2019 final guidance: Refuse to Accept Policy for 510(k)s. The minor updates and clarifications include: Correction of broken links Providing additional clarity that devices ineligible for 510(k) (for example, a device type classified in class III requiring PMA) may be refused by

Racial and Ethnic Diversity in Clinical Trials
26 Apr

FDA Update: FDA’s Outlines Racial Diversity for Clinical Trials

Finally it is recognized that racial and ethnic diversity are more than skindeep as the FDA takes important steps to increase diversity in clinical trials. Agency’s Focus on Inclusion in Trials for All Medical Products Aligns with Biden Administration’s Cancer Moonshot Goal of Addressing Inequities and Beyond. The U.S. Food and Drug Administration issued a

19 Apr

FDA Update: Can a Breathalzyer Actually Detect the Presence of COVID-19?

New medical technologies are always being developed to make things easier. Here is a new Covid test that would make things a lot easier for determining the presence of Covid. The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to InspectIR Systems for their InspectIR COVID-19 Breathalyzer test. The InspectIR COVID-19

14 Feb

FDA Update: Leave Tunnels for Transportation Purposes Only

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

10 Feb

FDA update: Warning – The FDA Restarts Routine Domestic Surveillance Inspections

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

COVID Testing Kits
08 Feb

The FDA Advises Consumers to Not Use E25Bio – COVID Testing Kits .

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

22 Dec

FDA Update: Visible Particulates Can Harm Patients

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,

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