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
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
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
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
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
FDA Announces New Environmental and Public Health Initiative To Streamline EtO Sterilization Methods As a part of the U.S. Food and Drug Administration’s (FDA) ongoing effort to streamline certain changes to ethylene oxide (EtO) sterilization processes and facilities, the FDA is announcing a 510(k) Sterility Change Master File Pilot Program. This new pilot program is
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
More and more drugs are being compounded by compound pharmacies. The FDA does regulate compound pharmacies and periodically these companies and drugs run into a problem that require a recall. FDA is alerting patients, health care professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC, doing business as APS Pharmacy, of
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
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
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