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22 Jun

FDA Update: FDA Issues Final Guidance about Technical Performance Assessments for Quantitative Imaging in Premarket Submissions

FDA Update Periodically the FDA issues Guidance documents for 510(k) submissions. here is a recent one for Radiological devices. FDA Issues Final Guidance about Technical Performance Assessments for Quantitative Imaging in Premarket Submissions The U.S. Food and Drug Administration (FDA) issued the final guidance, Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions. This

Animal Drugs and CBD
01 Jun

FDA Update: The FDA Wants to Know as They Issue Warnings to Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals

Is the Safety of Our Food Supply Compromised? FOR YOUR INFORMATION The FDA Wants to Know as They Issue Warnings to Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals The U.S. Food and Drug Administration (FDA) has issued warning letters to four companies illegally selling unapproved animal drugs containing cannabidiol

medical gases
23 May

FDA UPDATE: FDA outlines new GMP rules for Medical Gases

FDA outlines new GMP rules for Medical Gases IMPORTANT CHANGES Please take notice FDA came out with a new proposed rule for certain Medical Gases titled “Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases.”.  FDA estimates this ruling will affect approximately 1,696 firms in the medical gases industry

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

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