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
FDA Update: Advance Planning and Supply Chain Management Can Save Lives in Case of a Disaster National Preparedness Month: Tips for Medical Device Manufacturers and Distributors Disasters can strike at any time. These emergency situations can disrupt the supply chain and threaten the availability of medical devices. In support of National Preparedness Month, the U.S.
FDA Updates to the Catalog of Regulatory Science Tools to Help Assess New Medical Devices The U.S. Food and Drug Administration (FDA) updated its Catalog of Regulatory Science Tools by adding four new tools and updating nine. The Catalog of Regulatory Science Tools is a peer-reviewed resource with over 120 tools, including phantoms and lab
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
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