1}> Submissions for devices with this product code take an average of { Math.round(result.average) } days to clear the FDA, but that's only a small part of the journey.
Contact in2being to find out how we can help develop your { committee_abbr[opts.docinfo.review_panel] } device and keep you on the right path.
Class I devices like these often don't require an FDA submission, but are still regulated by the FDA.
Contact in2being to find out how we can help develop your { committee_abbr[opts.docinfo.review_panel] } device and keep you on the right path.
Class III devices like these are the most regulated and require an extensive development effort and pre-market approval by the FDA.
Contact in2being for guidance on developing your { committee_abbr[opts.docinfo.review_panel] } device and keeping you on the right path.
Unclassified devices like these are pre-amendment devices where a regulation has not been enacted. These devices require a 510(k) submission.
Contact in2being for guidance on developing your { committee_abbr[opts.docinfo.review_panel] } device and keeping you on the right path.
Devices like these are non-classified { unclass_reason[opts.docinfo.unclassified_reason] }.
Contact in2being for guidance on developing your { committee_abbr[opts.docinfo.review_panel] } device and keeping you on the right path.