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FDA Update FDA Releases Draft Guidance on Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations FDA Issues Draft Guidance to Improve Accuracy and Address Bias in Pulse Oximeters The FDA has released a draft guidance document aimed at improving the accuracy of pulse oximeters and addressing concerns
FDA Update BD receives FDA warning letter over quality system violations Becton Dickinson (BD) has received a warning letter from the FDA regarding quality system violations at a facility that manufactures its Pyxis medication management system. The FDA identified several concerns, including: Failure to adequately investigate complaints: The FDA found over 92,000 complaints related to
Yes, the FDA has come out with the new FDA user fees for 2024. And as you can imagine the FDA is raising all fees from the annual registration to the 510(k)s. Annual Establishment Registration Fee for the coming year will be: $7,653 (talk about inflation – that is a 17% increase in the annual
GMP vs. ISO There has been a great deal of confusion concerning whether being in compliance with the medical device Good Manufacturing Practices (GMP) would successfully lead to obtaining ISO certification (with minimum changes and costs), or whether achieving ISO certification is going to be a long, expensive road. The ultimate success of your ISO
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