US FDA Medical Devices

FDA: 2023 Medical Device User Fees Announcement Medical device user fees for the Fiscal Year 2023 are now available following an announcement from the U.S. Food and Drug Administration (FDA). The fiscal year runs from October 1, 2022 – September 30, 2023. All medical device facilities must pay the new fee amounts to keep their

FDA: 2023 Medical Device User Fees Announcement Medical device user fees for the Fiscal Year 2023 are now available following an announcement from the U.S. Food and Drug Administration (FDA). The fiscal year runs from October 1, 2022 – September 30, 2023. All medical device facilities must pay the new fee amounts to keep their

Latest Medical Device User Fee Amendment (2022) FDA has released the new medical device user fee amendment (MDUFA) for 2022.   The US Food and Drugs Administration has established a 2.5% increase in Fees charged to Medical Devices manufacturers. This fee increase includes applications for Premarket Approval, 510(k) clearance, establishment registration and other applications in

FDA Requirements for Surgical and Non-Surgical Face Masks In the United States, face masks are regulated by the Food and Drug Administration (FDA) based on their intended use. This article outlines the regulatory requirements for both surgical and non-surgical face masks. Surgical Masks Definition: Surgical masks are intended for use by healthcare professionals during procedures

FDA registration requirements to import Face Mask   Guidelines to import face mask and FDA registration Non-surgical Face mask (no EUA required)    Register as an importer, and have your manufacturer the FDA registration as a medical device manufacturing establishment with FDA. List the medical device product that you intend to import. (FDA’s fee is