In order to gain the FDA approval the company would have to recheck their design specification document, which would state the detailed spec of the product. The company would be required to then check the amount of belladonna within the teething products to verify that the input they state is the same as the output. Since we know it is not the same they will be required to change their design input document. If you modify the DID then automatically the Design output document, DSD, design verification/ validation will all need to be updated. The FDA will scrutinize the Risk Analysis therefore, the project team will be required to update the statistical data supporting the new changes in the device so that the belladonna values will decrease. All of these edits will only be completed once a design change request is completed. The project team will have to approve of all the changes and then submit all the proper Design control forms to the manufacturers to manufacture the homeopathic teething product. Then only will the company be able to submit the proper regulation documents to the FDA for an approval process.