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
FDA Update For In Vitro Diagnostic Test Developers: Updates to the FDA’s Clinical Laboratory Improvement Amendments (CLIA) Web Pages Make Processes Clearer, Easier to Understand The Clinical Laboratory Improvement Amendments (CLIA) and the associated regulations provide the authority for oversight of clinical laboratories and laboratory testing. While the Centers for Medicare and Medicaid Services (CMS)
FDA Update mdi likes to get important information out to the public. New Available Material Makes for a More Informed Patient As… FDA Provides Information on Surgical Mesh Used for Hernia Repair The U.S. Food and Drug Administration (FDA) is providing information for consumers on surgical mesh used for hernia repair. This information includes: Types
FDA Update Assuring the Quality of Medicines is Not So Plain and Simple Report on the State of Pharmaceutical Quality The mission of the Office of Pharmaceutical Quality is to assure that quality medicines are available to the American public. This mission is not easy, but it is critically important. As our new Fiscal Year
FDA Update FDA Issues Final Guidance on Content of Premarket Submissions for Device Software Functions The U.S. Food and Drug Administration (FDA) issued the final guidance: Content of Premarket Submissions for Device Software Functions. The final guidance provides information regarding the recommended documentation sponsors should include in premarket submissions for the FDA’s evaluation of the
FDA Update Warning: Certain Tattoo Inks Can Cause Serious Illnesses… FDA Issues Draft Guidance on Tattoo Inks The U.S. Food and Drug Administration recently issued draft guidance on tattoo ink to manufacturers and distributors to help recognize situations in which a tattoo ink may become contaminated with microorganisms, and thus, be potentially injurious to health. This
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