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Tag Archives: 510(k) preparation

22 Jun

FDA Update: FDA Issues Final Guidance about Technical Performance Assessments for Quantitative Imaging in Premarket Submissions

FDA Update Periodically the FDA issues Guidance documents for 510(k) submissions. here is a recent one for Radiological devices. FDA Issues Final Guidance about Technical Performance Assessments for Quantitative Imaging in Premarket Submissions The U.S. Food and Drug Administration (FDA) issued the final guidance, Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions. This

02 May

FDA Update: The FDA Continues to Streamline their Process As They Announce Minor Updates to Refuse to Accept Policy for 510(k)s – Final Guidance Helps to Clarify What Is Acceptable to the FDA

On April 25, 2022 the U.S. Food and Drug Administration (FDA) updated the 2019 final guidance: Refuse to Accept Policy for 510(k)s. The minor updates and clarifications include: Correction of broken links Providing additional clarity that devices ineligible for 510(k) (for example, a device type classified in class III requiring PMA) may be refused by

12 Aug

FDA UPDATE: 2022 FDA USER FEES ANNOUNCED

No Surprise – Effective October 1, 2021 FDA User Fees Will Increase  These fees will be effective through September 30, 2022. Fortunately, the increases will not be too large for FY2022. The FDA annual registration fee for each establishment is $5,672 (in United States dollars) up from the $5546 of 2021. As previously, there are

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