Medical Innovation Exchange

510(k)

510k Submission Planning

510k Submission Planning     With an aim to provide thoughtful insight on how to go about planning a 510(k) submission long before the writing begins, we have created this helpful list of top tips, where we will outline the items you should be aware of when planning your 510K submission. Tip #1: Visit the FDA …

510k Submission Planning Read More »

FDA CDRH Portal Now Offers Tracking of Pre-Submissions

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 …

FDA CDRH Portal Now Offers Tracking of Pre-Submissions Read More »

The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR

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 …

The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR Read More »