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Hi, all
A nonUS medical device manufacturer, Company A, submitted
a 510(k) for a medical device that was marketed in the US.
The owner of the company A decided to close the company
and founded Company Y, which was also outside the US.
Questions as following:
1. If company A would like to transfer 510(k) ownership, how to transfer?
who could do this job?If US agent of company Y could do this job, or it should deal by US agent of company A?
2. After transferring, if the 510(k) ownership in the fda database will be showner as Company Y? If not, what other record could prove that?
3. After transferring, what's obligation should Company A bear for the products had marketed in US? Could these obligations transfer to company Y? What doc or record should transfer to COMPANY y at the same time with transferring the ownership of 510(k)?
Any comment will be appreciated! Thanks in advance!
A nonUS medical device manufacturer, Company A, submitted
a 510(k) for a medical device that was marketed in the US.
The owner of the company A decided to close the company
and founded Company Y, which was also outside the US.
Questions as following:
1. If company A would like to transfer 510(k) ownership, how to transfer?
who could do this job?If US agent of company Y could do this job, or it should deal by US agent of company A?
2. After transferring, if the 510(k) ownership in the fda database will be showner as Company Y? If not, what other record could prove that?
3. After transferring, what's obligation should Company A bear for the products had marketed in US? Could these obligations transfer to company Y? What doc or record should transfer to COMPANY y at the same time with transferring the ownership of 510(k)?
Any comment will be appreciated! Thanks in advance!