Points to consider for premarket notification [510(k)] submissionMarch 21, 2023
Points to consider for premarket notification [510(k)] submission
March 21, 2023
Does your regulatory strategy indicate that the most appropriate regulatory path to market your device in the US is 510(k)?
Did you ask yourself what next?
Consider the following key points:
▪ Start by thinking about what are you going to say about your device when
you will market it in the US.
▪ Choose the appropriate predicate device to demonstrate substantial equivalence according to your marketing claims, intended use, and technical characteristics.
▪ Determine the 510(k) types (traditional, special, or abbreviated) and prepare the submission accordingly.
▪ Have all required tests and data to support your submission (using recognized consensus standards and relevant FDA guidance).
▪ Ensure the advocacy of your 510(k), it is not sufficient to have evidentiary documents only.
▪ Ensure the data integrity of your submission and use good submission practices to enable smooth review.
▪ Get to know the eSTAR (Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR).
▪ Understand the impact of MDUFA metrics on FDA actions.
▪ Be familiar with the options to communicate with the FDA (before and during the submission).
▪ Get to know the function of the CDRH Deputy Ombudsman (in case you will need to contact him).
March 21, 2023
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