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 Proposes Requirements for How Requestors Can Make Minor Dosage Form Changes to Certain Over-the-counter Monograph Drugs The U.S. Food and Drug Administration (FDA) is proposing requirements for how requestors can make minor dosage form changes to certain over-the-counter (OTC) monograph drugs. FDA issued Proposed Administrative Order OTC000038 that, if finalized, will specify
FDA Update – January 17, 2025 FDA Releases Draft Guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency The FDA has issued a new draft guidance to help developers validate diagnostic tests (IVDs) for emerging pathogens during public health emergencies. This guidance aims to ensure that
FDA Update FDA Releases Draft Guidance on Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations FDA Issues Draft Guidance to Improve Accuracy and Address Bias in Pulse Oximeters The FDA has released a draft guidance document aimed at improving the accuracy of pulse oximeters and addressing concerns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
FDA Update December 6, 2024 COVID Public Health Emergency Exemption from Fees to Expire FDA Reminds OTC Hand Sanitizer Manufacturers of OMUFA Facility Fees for FY 2025 FDA is reminding companies who registered with the agency solely to manufacture hand sanitizer during the COVID-19 public health emergency that they are subject to fiscal year (FY)
FDA Update FDA Introduces Streamlined Complaint Process in New Human Foods Program The U.S. Food and Drug Administration (FDA) has recently announced a streamlined process for submitting complaints related to human foods. This new approach aims to improve the agency’s ability to detect and respond to potential problems with FDA-regulated products, including foods and dietary
FDA Update Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers – Guidance for Industry The U.S. Food and Drug Administration (FDA) has recently released a guidance document that directly affects our industry: Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers – Guidance for Industry. The guidance hopes to provide clarity on the VMSR program. The
FDA Update – Remanufacturing of Medical Devices – Guidance for Industry The U.S. Food and Drug Administration (FDA) has recently released a guidance document that directly affects our industry: Remanufacturing of Medical Devices – Guidance for Industry. The guidance aims to provide clarity on what actions performed are considered “remanufacturing.” The FDA intends to provide
FDA Update With the New Fiscal Year Just Around the Corner the FDA announced the new USER FEE for ’25. The FDA Has Just Announced Their User Fees for FY 2025 The FDA has again raised the user fees for the annual registration for medical devices along with all the required submissions. the FDA still
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