MDUFA | Third Party Review Group

FDA Mandatory eStar/ESG submission and Expedited 510K Clearance

Posted on April 1, 2023June 8, 2023 by Catherine Read

FDA Mandatory eStar/ESG submission and Expedited 510(k) Clearance Posted on April 1, 2023 by Catherine Read The Third Party Review Group or just TPRG for short is an FDA accredited review organization. There are very few companies qualified to review 510K submissions for the FDA and TPRG is celebrating their 13th year performing this work […]

FDA MDUFA Fee

Posted on October 1, 2022June 8, 2023 by Catherine Read

FDA Clearance and 2023 Medical Device User Fees – MDUFA Posted on October 1, 2022 by Catherine Read The Medical Device User Fee or MDUFA is a funding source for the FDA. As a medical device manufacturer, it is important to understand why you are paying this fee and what it will get you. The MDUFA […]