FDA Update FDA Request for Advisory Committee Nominations: Consumer Organizations and Individuals The Food and Drug Administration seeks input from consumers on medical and scientific issues. A key method of ensuring that FDA obtains the points of view of consumers is by including Consumer Representatives on Agency advisory committees. The FDA, relies on their many
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
CMG, a Canadian based medical supply manufacturer, supply chain management services provider, and fully integrated services provider, supplying certification and consulting services to global healthcare enterprises. CMG is proud to partner with mdi Consultants for global regulatory services for FDA, Health Canada, and other jurisdictions; and, Kinectrics.com for ASTM product certifications CGM Corporate office is headquartered
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
mdi Consultants