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
FDA Update The Safety of Syringes Imported into the US Called into Question As: The FDA Sends Two Warning Letters after Inspecting Chinese Syringe Manufacturers The FDA named companies Jiangsu Shenli and Jiangsu Caina as targets of its investigation into the safety of plastic syringes made in China in March. The agency had not completed
FDA Update FDA Revises Final Guidance Combination Products Update The U.S. Food and Drug Administration published the revised final guidance Application User Fees for Combination Products. This guidance replaces the final guidance of the same title issued in 2005, and includes revisions for consistency with the current user fee programs and revisions to reflect combination
FDA Update No More Free Rides As FDA Reinstates OMUFA Facility Fees as of 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) 2025 OMUFA facility fees, unless they delist and deregister before 12 a.m.
FDA Update As June Is Upon Us the FDA Recommends Planning Ahead As… and sending out notices to all medical device companies. Hurricane Season Can Affect the Medical Device Community and Patients Too When we think of hurricanes we think of structural disasters with people losing their lives and their homes, and most often we
FDA Update FDA Advises Against Using Cue Health COVID-19 Tests, Sends Warning Letter THIS should not be coming as a surprise. The FDA is back going out to the companies and performing inspections. Many companies that may have been operating under the EUA from Covid days, are now being inspected and running into FDA regulatory
FDA Update FDA Publishes Landmark Final Rule to Enhance the Safety of Agricultural Water mdi thought you would be interested in this new rule!!! The U.S. Food and Drug Administration (FDA) published a final rule on agricultural water that represents an important step toward enhancing the safety of produce. The revised requirements are intended to enhance public
FDA update April 11, 2024 Federal District Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines A federal district court entered a consent decree against Philips Respironics (Philips). The consent decree includes key provisions aimed to prioritize patient relief and ensure the company’s regulatory compliance. The consent decree comes after
FDA Crisis Intervention Though we hope this never occurs, at times companies do run into situations they were not prepared for, or understand, while dealing with the FDA. We have seen this over and over again with our clients worldwide. These unexpected situations could be: A Surprise FDA Inspection Visit When the FDA gets information
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