Short answer: Before Q3 begins, medical device companies should verify five key compliance areas: FDA establishment registration, QMSR implementation, inspection readiness, U.S. Agent designation (for foreign manufacturers), and the status of any open FDA 483 corrective actions. Addressing these items now can help avoid compliance issues and last-minute challenges during the October registration renewal period.
For foreign medical device firms, FDA establishment registration and U.S. Agent designation are not optional—they are mandatory requirements for accessing the U.S. market. Errors in either process can lead to shipment delays, import holds, or FDA Import Alerts that disrupt business operations and market access. Drawing on nearly 50 years of regulatory experience and
What FDA Inspectors Are Actually Checking Under the New QMSR — MDI’s First-Hand Findings The single biggest focus area in every QMSR inspection that MDI has participated in is not your quality manual, SOPs/work instruction, documentation structure or your terminology — it is your organizations ability to demonstrate risk-based thinking embedded throughout your entire quality
FDA Opens the Door to Sunscreen Innovation: First New UV Filter Approved in Over 20 Years! The U.S. Food and Drug Administration (FDA) has finalized an administrative order adding bemotrizinol to the Over-the-Counter (OTC) Sunscreen Monograph, making it the first new sunscreen active ingredient approved for inclusion in the U.S. OTC sunscreen framework in more
The FDA themselves state it is industry’s responsibility to work with investigators before they leave the company to remove all incorrect points on the 483. The FDA is also supposed to annotate the 483 concerning your corrective actions that were accomplished during the inspection. From latest experience with the new FDA investigators, this advice doesn’t
FDA Update PLEASE BE AWARE THAT THE FDA HAS LAUNCHED THE FOLLOWING PROGRAM. WHAT DOES IT MEAN TO YOU? FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight The U.S. Food and Drug Administration today announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources
The FDA posts various areas of concerns as they see them developing. We will try to provide them to you for your review and knowledge. Here is the April 13, 2026 on Food Economic motivated Adulteration – Honey The U.S. Food & Drug Administration is releasing data from a sampling assignment carried out in 2025 to test
We recently participated in FDA inspections using the new QMSR (Quality Management Systems Regulations). These inspections were very interesting. One was conducted at a foreign client in China the other was in the USA. These inspections went directly to the QMSR and expected that the companies were following the new regulations. If you are already
ISO 10993-6 Update: Implantation Test Methods for Medical Devices ISO 10993-6 is part of the ISO 10993 series, a globally recognized framework for the biological evaluation of medical devices. Specifically, Part 6 focuses on implantation studies, which are designed to assess the local effects of medical devices or materials when placed within living tissue. These
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