When I submit a 510(k) eSubmission for OIVD using the FDA eSubmitter software, do I need to include hardcopies of the 510(k)?
Related Questions
- What if the standard I want to reference in the eSubmission (section 7.0 of the Admin tab) is not listed in the FDA eSubmitter software database?
- When I submit a 510(k) eSubmission for OIVD using the CeSub eSubmitter software, do I need to include hardcopies of the 510(k)?
- When I submit a 510(k) eSubmission for OIVD using the FDA eSubmitter software, do I need to include hardcopies of the 510(k)?
