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Category Archives: FDA Updates

Drug Supply Chain Security Act
07 Jul

FDA Update: FDA Issues Two Draft Guidances Related to the Drug Supply Chain Security Act

Further Protection Against Counterfeit, Stolen, Contaminated, or Otherwise Harmful Drugs is On the Way FDA is announcing the availability of two guidances to help trading partners comply with the Drug Supply Chain Security Act (DSCSA). These documents are critical steps toward implementing the DSCSA enhanced drug distribution security requirements that will go into effect on

Food importer news
27 Jun

FDA Update: Food Importer News

IMPORTANT 30-DAY NOTICE FOR FSVP IMPORTERS RE: “UNK” Food Importer News from the U.S. FDA Center for Food Safety and Applied Nutrition  NEW for food importer – Beginning July 24, 2022, the entity identification code “UNK” will no longer be accepted in the Entity Number field by U.S. Customs and Border Protection (CBP). Consistent with

22 Jun

FDA Update – PULSE OXIMETERS

FDA Update – PULSE OXIMETERS The FDA has some concerns on the precision on Pulse Oximeters when it is used by people of different skin tones. They recently came out with this update. Can Skin Tone Affect the Precision of Pulse Oximeters?  The FDA is Working to Determine the Accuracy As Well As Limitations The

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

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