Regulatory Open Forum

Hello Forum members,

I am hoping to receive information in regard to FDA establishment registration specifically to the business address.

The concept of a physical office address is becoming more redundant. In the example presented, a med dev company registered with the FDA (foreign establishment with no on-site manufacturing i.e. uses a CMO) which initially had a physical business office, is now moving to a remote working arrangement such that the office address will cease. CMO manufacturing has since paused and devices remain in distribution.

The country where the business is registered still requires a registered business address to operate and in these situations the company may be registered with a legal firm and use that address as the 'business' address. Sounds a little complicated, but this allows a company which does not have a physical business location to operate. 

Has anyone in the forum had experience with this situation and would the use of a business address that is under a different firm's name be acceptable for FDA establishment registration? 

Thank you.

Hello Anon,

When entering the address on the FDA's FURLS database, first it must be clear on the designation of the registration: identified as the Manufacturer, Specification Developer, etc., which can be reviewed here: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee.  The address entered in the FURLS database, can be any address - even if this address may be associated with another company.  What is really important is when FDA contacts the company to conduct an inspection in a foreign country (or even domestic) there must be a physical place the investigator would go to the "facility."  This means the address used for a foreign Manufacturer must be clear there is a physical place the investigator can arrive.  It would not be recommended to have a virtual address in the FURLS database because it would cause many difficulties during an inspection - and may raise suspicion or concern about the company itself.

Hello Forum members,

I am hoping to receive information in regard to FDA establishment registration specifically to the business address.

The concept of a physical office address is becoming more redundant. In the example presented, a med dev company registered with the FDA (foreign establishment with no on-site manufacturing i.e. uses a CMO) which initially had a physical business office, is now moving to a remote working arrangement such that the office address will cease. CMO manufacturing has since paused and devices remain in distribution.

The country where the business is registered still requires a registered business address to operate and in these situations the company may be registered with a legal firm and use that address as the 'business' address. Sounds a little complicated, but this allows a company which does not have a physical business location to operate. 

Has anyone in the forum had experience with this situation and would the use of a business address that is under a different firm's name be acceptable for FDA establishment registration? 

Thank you.

Hello Anon,

When entering the address on the FDA's FURLS database, first it must be clear on the designation of the registration: identified as the Manufacturer, Specification Developer, etc., which can be reviewed here: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee.  The address entered in the FURLS database, can be any address - even if this address may be associated with another company.  What is really important is when FDA contacts the company to conduct an inspection in a foreign country (or even domestic) there must be a physical place the investigator would go to the "facility."  This means the address used for a foreign Manufacturer must be clear there is a physical place the investigator can arrive.  It would not be recommended to have a virtual address in the FURLS database because it would cause many difficulties during an inspection - and may raise suspicion or concern about the company itself.

Hello Forum members,

I am hoping to receive information in regard to FDA establishment registration specifically to the business address.

The concept of a physical office address is becoming more redundant. In the example presented, a med dev company registered with the FDA (foreign establishment with no on-site manufacturing i.e. uses a CMO) which initially had a physical business office, is now moving to a remote working arrangement such that the office address will cease. CMO manufacturing has since paused and devices remain in distribution.

The country where the business is registered still requires a registered business address to operate and in these situations the company may be registered with a legal firm and use that address as the 'business' address. Sounds a little complicated, but this allows a company which does not have a physical business location to operate. 

Has anyone in the forum had experience with this situation and would the use of a business address that is under a different firm's name be acceptable for FDA establishment registration? 

Thank you.

It may also be challenging to get a DUNS number to use in GUDID, unless Dun & Bradstreet has started allowing virtual addresses.

Hello Anon,

When entering the address on the FDA's FURLS database, first it must be clear on the designation of the registration: identified as the Manufacturer, Specification Developer, etc., which can be reviewed here: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee.  The address entered in the FURLS database, can be any address - even if this address may be associated with another company.  What is really important is when FDA contacts the company to conduct an inspection in a foreign country (or even domestic) there must be a physical place the investigator would go to the "facility."  This means the address used for a foreign Manufacturer must be clear there is a physical place the investigator can arrive.  It would not be recommended to have a virtual address in the FURLS database because it would cause many difficulties during an inspection - and may raise suspicion or concern about the company itself.

Hello Forum members,

I am hoping to receive information in regard to FDA establishment registration specifically to the business address.

The concept of a physical office address is becoming more redundant. In the example presented, a med dev company registered with the FDA (foreign establishment with no on-site manufacturing i.e. uses a CMO) which initially had a physical business office, is now moving to a remote working arrangement such that the office address will cease. CMO manufacturing has since paused and devices remain in distribution.

The country where the business is registered still requires a registered business address to operate and in these situations the company may be registered with a legal firm and use that address as the 'business' address. Sounds a little complicated, but this allows a company which does not have a physical business location to operate. 

Has anyone in the forum had experience with this situation and would the use of a business address that is under a different firm's name be acceptable for FDA establishment registration? 

Thank you.

Hello Anon,

When entering the address on the FDA's FURLS database, first it must be clear on the designation of the registration: identified as the Manufacturer, Specification Developer, etc., which can be reviewed here: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee.  The address entered in the FURLS database, can be any address - even if this address may be associated with another company.  What is really important is when FDA contacts the company to conduct an inspection in a foreign country (or even domestic) there must be a physical place the investigator would go to the "facility."  This means the address used for a foreign Manufacturer must be clear there is a physical place the investigator can arrive.  It would not be recommended to have a virtual address in the FURLS database because it would cause many difficulties during an inspection - and may raise suspicion or concern about the company itself.

Hello Forum members,

I am hoping to receive information in regard to FDA establishment registration specifically to the business address.

The concept of a physical office address is becoming more redundant. In the example presented, a med dev company registered with the FDA (foreign establishment with no on-site manufacturing i.e. uses a CMO) which initially had a physical business office, is now moving to a remote working arrangement such that the office address will cease. CMO manufacturing has since paused and devices remain in distribution.

The country where the business is registered still requires a registered business address to operate and in these situations the company may be registered with a legal firm and use that address as the 'business' address. Sounds a little complicated, but this allows a company which does not have a physical business location to operate. 

Has anyone in the forum had experience with this situation and would the use of a business address that is under a different firm's name be acceptable for FDA establishment registration? 

Thank you.

Agreed with Richard. And would add that, even if the CMO has ceased operations (presumed to mean that no further manufacturing of the device in question is happening), the reason a virtual manufacturer must still register a physical address where FDA can go for an inspection is because such a virtual manufacturer still has ongoing FDA regulatory obligations (e.g., complaint handling, MDR reporting, corrective action, recall if needed, inventory control for any premade stock, etc.). The registration needs to be in the responsible manufacturer's name. The notion of using a different person's name could raise questions and difficulties for both parties. FDA's regulatory/registration requirements are not driven by corporate legalities, but instead by the operations in which a firm is engaged and responsible.

Hello Anon,

When entering the address on the FDA's FURLS database, first it must be clear on the designation of the registration: identified as the Manufacturer, Specification Developer, etc., which can be reviewed here: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee.  The address entered in the FURLS database, can be any address - even if this address may be associated with another company.  What is really important is when FDA contacts the company to conduct an inspection in a foreign country (or even domestic) there must be a physical place the investigator would go to the "facility."  This means the address used for a foreign Manufacturer must be clear there is a physical place the investigator can arrive.  It would not be recommended to have a virtual address in the FURLS database because it would cause many difficulties during an inspection - and may raise suspicion or concern about the company itself.

Hello Forum members,

I am hoping to receive information in regard to FDA establishment registration specifically to the business address.

The concept of a physical office address is becoming more redundant. In the example presented, a med dev company registered with the FDA (foreign establishment with no on-site manufacturing i.e. uses a CMO) which initially had a physical business office, is now moving to a remote working arrangement such that the office address will cease. CMO manufacturing has since paused and devices remain in distribution.

The country where the business is registered still requires a registered business address to operate and in these situations the company may be registered with a legal firm and use that address as the 'business' address. Sounds a little complicated, but this allows a company which does not have a physical business location to operate. 

Has anyone in the forum had experience with this situation and would the use of a business address that is under a different firm's name be acceptable for FDA establishment registration? 

Thank you.

Hello Anon

Another point... If your workspace is in your home(s) rather than in an office, it is still possible for it to be inspected, though it may be less convenient. See chapter 5 of the Investigations Operations Manual, §5.1.4.3:  https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual

Agreed with Richard. And would add that, even if the CMO has ceased operations (presumed to mean that no further manufacturing of the device in question is happening), the reason a virtual manufacturer must still register a physical address where FDA can go for an inspection is because such a virtual manufacturer still has ongoing FDA regulatory obligations (e.g., complaint handling, MDR reporting, corrective action, recall if needed, inventory control for any premade stock, etc.). The registration needs to be in the responsible manufacturer's name. The notion of using a different person's name could raise questions and difficulties for both parties. FDA's regulatory/registration requirements are not driven by corporate legalities, but instead by the operations in which a firm is engaged and responsible.

Hello Anon,

When entering the address on the FDA's FURLS database, first it must be clear on the designation of the registration: identified as the Manufacturer, Specification Developer, etc., which can be reviewed here: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee.  The address entered in the FURLS database, can be any address - even if this address may be associated with another company.  What is really important is when FDA contacts the company to conduct an inspection in a foreign country (or even domestic) there must be a physical place the investigator would go to the "facility."  This means the address used for a foreign Manufacturer must be clear there is a physical place the investigator can arrive.  It would not be recommended to have a virtual address in the FURLS database because it would cause many difficulties during an inspection - and may raise suspicion or concern about the company itself.

Hello Forum members,

I am hoping to receive information in regard to FDA establishment registration specifically to the business address.

The concept of a physical office address is becoming more redundant. In the example presented, a med dev company registered with the FDA (foreign establishment with no on-site manufacturing i.e. uses a CMO) which initially had a physical business office, is now moving to a remote working arrangement such that the office address will cease. CMO manufacturing has since paused and devices remain in distribution.

The country where the business is registered still requires a registered business address to operate and in these situations the company may be registered with a legal firm and use that address as the 'business' address. Sounds a little complicated, but this allows a company which does not have a physical business location to operate. 

Has anyone in the forum had experience with this situation and would the use of a business address that is under a different firm's name be acceptable for FDA establishment registration? 

Thank you.