This message was posted by a user wishing to remain anonymous
Hi Laura,
I know this question was posted a bit ago. However, do you have an answer in a situation were the original physical manufacturer does no longer owns the 510K and will no longer be the manufacturer?
1- Do the 510K owner, also owns the registration, labeling and device supporting responsibilities both with previous and future customers in USA and EU?
2- Is the previous physical manufacturer required to support customer that acquired the instrument prior to the acquisition date of the 510K in the USA and EU?
3- Is the previous physical manufacturer required to maintain the registrations and labels?
Bests regards
Original Message:
Sent: 26-Sep-2019 11:09
From: LAURA HOSHUE
Subject: Responsible parties - Manufacturer vs Owner of 510(k)
Hello fellow Rappers!!!
FDA requires any registered product should have a responsible party for all the liabilities. However, at this moment, neither the owner of the 510(k) and US distributor (not the physical manufacturer), nor has the physical manufacturer regarded itself to be such party. In such situation, what are the options when registering?
- Does the physical manufacturer register itself as manufacturer of the product whose 510(k) is owned by the distributor (to date there are several registered products under the physical manufacturer's name but not that of the owner of the 510(k)/distributor.
- Does the distributor/owner of the 510(k) register itself as the developer of specification?
What are the proper steps to take as it pertains to registering with FDA? It is always a tricky situation. I have read the definition of the manufacturer per FDA, but not sure how to register in FURLS.
Advice anyone?
Thank you!
Laura
------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------