21CFR807.25 (d) Owner-Operator Contact question

[ajbera3]

Per 21CFR807.25 (d), "Each owner or operator is required to maintain a listing of all officers, directors, and partners for each establishment..."

Per 21CFR807.25 (e), "Each owner or operator shall also provide FDA with the name of a contact person at the owner or operator's offices who will be responsible for identifying the official correspondent for each establishment. The owner or operator contact person will be the official correspondent in the event no one else has been properly designated."

The Owner-Operator Contact person doesn't need to be an officer, director, or partner, correct? We have a "Site Lead" who has been with the company for years as upper management (with significant regulatory experience) but not as a corporate officer or partner. My assumption is that there is nothing to disqualify him from being the OO Contact, but I'm seeking confirmation of this assumption. We have a separate Official Correspondent who would rather not be the OO Contact.

Thanks.

 

[Ajit Basrur]

Welcome to the Cove

https://www.fda.gov/MedicalDevices/...ce/RegistrationandListing/ucm318796.htm#FURLS

The owner/operator (O/O) account can be thought of as the primary account, as it can make any changes in DRLM.

The responsibilities include :

Creating and updating all of the OC accounts, including their own account(s) and keeping them up-to-date (the O/O is the ONLY one that can do so)

Assigning an OC to registered establishments (by creating subaccounts), and making changes to them when appropriate

Acting as the official correspondent if the O/O does not create a separate OC account

Making additions and updates to, and deactivating ALL registrations and listings having the same O/O, if an O/O account has multiple establishments

As long as the above can be met, any officer could become the Owner / Operator.

 

[Highground]

Hi @Ajit Basrur

We are registered as distributer and spectification developer. Do I need to add devices that we import to the DRLM and do we have to list the devices we develope software for?