Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

A manufacturing company is being acquired through a process where the old company (OLD-comp) will no longer exist while a new one (NEW-comp) is created to continue doing the same manufacturing business, just with a new name (and under new owners). OLD-comp manufactures research use only (RUO) medical devices commercialized in the USA and EU.

What needs to happen for NEW-comp to continue manufacturing and commercializing RUO devices in USA and EU?. 

Is re-labeling required?

Are registrations renewals required?

I appreciate everyone's contribution to help me understand and prepare for this situation.

Kindly

Hi Anon,

that is difficult to answer without more details. It is probably safe to assume that re-labeling with the new responsible manufacturer and updating or renewing the existig registrations will be needed. How much work that will mean and what additional activities might be required depends a lot on the details of how the transformation tooke place, what jurisdiction acutally applies (are these medical devices or research use only products) and what products we are talking about exactly (e.g. device class).

Best regards,

Christoph

------------------------------
Christoph Kiesselbach
Schrack & Partner
Reutlingen
Germany
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Original Message:
Sent: 28-Mar-2024 16:30
From: Anonymous Member
Subject: Product Transfer during acquisition

This message was posted by a user wishing to remain anonymous

A manufacturing company is being acquired through a process where the old company (OLD-comp) will no longer exist while a new one (NEW-comp) is created to continue doing the same manufacturing business, just with a new name (and under new owners). OLD-comp manufactures research use only (RUO) medical devices commercialized in the USA and EU.

What needs to happen for NEW-comp to continue manufacturing and commercializing RUO devices in USA and EU?. 

Is re-labeling required?

Are registrations renewals required?

I appreciate everyone's contribution to help me understand and prepare for this situation.

Kindly

This message was posted by a user wishing to remain anonymous

Hi Anon

Can you clarify the kind of use these products are commercialized for? Investigational devices don't normally get registered or commercialized.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/distribution-in-vitro-diagnostic-products-labeled-research-use-only-or-investigational-use-only

Original Message:
Sent: 28-Mar-2024 16:30
From: Anonymous Member
Subject: Product Transfer during acquisition

This message was posted by a user wishing to remain anonymous

A manufacturing company is being acquired through a process where the old company (OLD-comp) will no longer exist while a new one (NEW-comp) is created to continue doing the same manufacturing business, just with a new name (and under new owners). OLD-comp manufactures research use only (RUO) medical devices commercialized in the USA and EU.

What needs to happen for NEW-comp to continue manufacturing and commercializing RUO devices in USA and EU?. 

Is re-labeling required?

Are registrations renewals required?

I appreciate everyone's contribution to help me understand and prepare for this situation.

Kindly