FDA recently announced the updated medical device fees for the 2024 fiscal year (October 1, 2023 – September 30, 2024). All medical device manufacturers, importers, and distributors must pay an annual establishment registration fee to FDA. Please do not wait until the...
UPDATE:Breaking News: The Medical Device User Fees have just been announced for FY2023. The Annual Establishment Registration Fee is $6,493. Other fees are now listed and can be found...
Over the past several years, the Food and Drug Administration (FDA) has been phasing in requirements for Unique Device Identifiers (UDI) to be displayed on various classes of medical devices. The UDI system identifies medical devices sold in the United States and is...
The Biden administration has declared monkeypox to be a public health emergency in the United States. This is going to likely result in emergency use authorizations (EUAs) for medical products to diagnose and perhaps even reduce the symptoms related to the spreading...
In July and August of 2021, the Food and Drug Administration (FDA) announced the revocation of the Emergency Use Authorizations (EUAs) for Gravity Diagnostics, LLC for the Gravity Diagnostics COVID-19 Assay, Materials and Machines Corporation of America for the...
UPDATE 12/30/2020: FDA publishes new OTC drug user fees, read more here. Original Post 08/27/2020: FDA has officially announced the updated drug and medical device fees for the 2021 fiscal year (October 1, 2020 – September 30, 2021). This includes fees associated with...
Between October 1 and December 31, certain Food and Drug Administration (FDA)-registered facilities must renew their registrations. Here are some things you need to know to ensure your renewal is completed on time. Medical device establishments: The process of paying...
The 21st century has brought us many new technologies that have improved lives, and now AdEchoTech has added one more innovation to the list: MELODY. 75 YEARS after the first sonography was used for medical diagnosis by neurologist Karl Dussick, AdEchoTech has...
The Microneedling industry developed and flourished without any substantive guidance from FDA other than periodic whack-a-mole enforcement actions. That changed today (Sept. 14, 2017) with FDA issuing a DRAFT guidance with the captivating name: “Regulatory...
Three experienced regulatory team members from FDAImports.com attended the Florida International Medical Expo (FIME) in Orlando with great success. We had excellent conversations with industry professionals all along the medical device development, production and...
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