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
FDA update We like to keep you abreast of various regulatory matters involving the FDA. we thought this was an interesting case. The U.S. Food and Drug Administration (FDA) is providing an important update on the Food and Drug Administration (FDA) and its partner agencies have recently announced charges against Bien King and Khalil King,
FDA Update It Is That Time of the Year Again… FDA Annual Establishment Renewal and Drug Listing Certification The annual establishment registration renewal and drug listing certification period is now open and will close on December 31, 2023. This does not apply to private label distributors. You may submit a Blanket No Changes Certification of
FDA Update FDA Addresses Electronic Efficiency Reminder: Starting October 1, 2023, Use of and Resource (eSTAR) and CDRH Portal are Required for 510(k) SubmisElectronic Submission Templatesions The U.S. Food and Drug Administration (FDA) is reminding all medical device submitters that starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions
We recently seen a new initiative from the FDA. The FDA seems to be reaching out to medical device companies that have been listing devices within the registration process that they are claiming to be covered under the device “pre-amendment” status. This is a very NEW initiative from the FDA and the first time we
FDA Update – September 6, 2023 Post-Warning Letter Meetings with FDA – Guidance for Industry The U.S. Food and Drug Administration (FDA) has recently released a guidance document that directly affects our industry: Post-Warning Letter Meetings With FDA – Guidance for Industry. The guidance provides information on the implementation of the post-warning letter meeting process
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