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 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
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
FDA UPDATE What FDA Inspectors Are Actually Checking Under the New QMSR — mdi’s First-Hand Findings The FDA’s QMSR replaced the old QSR on February 2, 2026 — and if your quality system documents still reference 21 CFR Part 820 sections instead of ISO 13485 clauses, your next FDA inspection will expose that gap immediately.
FDA UPDATE Medical Device User Fee Amendments (MDUFA) FY2026 – !Exciting News for Small Businesses! The FDA has officially released the Medical Device User Fees for FY2026, and there’s great news for small business firms! For the first time ever, the FDA is offering a waiver for the Annual Establishment Registration Fee—a huge win for
FDA Update Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act Final Guidance The U.S. Food and Drug Administration’s Center for Devices and Radiological Health’s new presentation, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of
FDA Update – June 25, 2025 Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers We are seeing more and more regulatory actions against foreign companies because of lack of FDA QSR compliance. When a company has a violative inspection, and the FDA does not accept their corrective
FDA Update FDA Releases Draft Guidance on Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations FDA Issues Draft Guidance to Improve Accuracy and Address Bias in Pulse Oximeters The FDA has released a draft guidance document aimed at improving the accuracy of pulse oximeters and addressing concerns
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