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FDA CDRH Portal Now Offers Tracking of Pre-Submissions On May 22, the FDA announced that it has updated the CDRH Portal to allow users to track the progress of Pre-Submissions. A submitter must specify the type of Pre-Submission request, which include: written feedback (only) written feedback followed by a meeting The agency noted that the …
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The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR Equivalence strategies can be used to efficiently demonstrate the safety of a medical device, limiting the need for new studies and testing. Given the level of investment that may be needed to achieve compliance with the EU Medical Device Regulation (MDR), leveraging equivalence may …
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