Hi Rob, does the Submission preparation fee also include the cost of creating documentation like design controls? or is it just the fee for filing the submission in the eSTAR format?
The preparation fee covers weekly meetings during the testing process, regulatory strategy, completion of the eSTAR, reviewing the test reports, helping with revisions to documentation including the device description and labels, but we don't create the attachments for you. We also provide templates for documents you don't have. We can help create the DHF on an hourly consulting basis or we can let the client do more of the eSTAR and we can help review and edit. So far we have seen very few people fill in the eSTAR without errors, but the errors are far less than without the eSTAR.
Individuals can submit a 510(k), but you still need to perform the testing, pay the FDA user fees, and in order to receive the small business discount you would apply as an individual instead of a firm.
Hi Rob, does the Submission preparation fee also include the cost of creating documentation like design controls? or is it just the fee for filing the submission in the eSTAR format?
The preparation fee covers weekly meetings during the testing process, regulatory strategy, completion of the eSTAR, reviewing the test reports, helping with revisions to documentation including the device description and labels, but we don't create the attachments for you. We also provide templates for documents you don't have.
We can help create the DHF on an hourly consulting basis or we can let the client do more of the eSTAR and we can help review and edit.
So far we have seen very few people fill in the eSTAR without errors, but the errors are far less than without the eSTAR.
Can i do a 510k as just some guy with a thing i made? Do i need to be a business?
Individuals can submit a 510(k), but you still need to perform the testing, pay the FDA user fees, and in order to receive the small business discount you would apply as an individual instead of a firm.