What is the best approach for a Class II Medical Device when its branding changes?

S

Silvertabb

#1
What is the best approach for a Class II device when its branding changes?
Note to file
510k
Other

Assumption: This device has had a few minor changes at different times. All changes captured as internal documentation per 510k analysis guidance.
 
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M

MIREGMGR

#2
Re: What is the best approach for a Class II Medical Device when its branding changes

Several scenarios:

The (regulatorily responsible) company changed their name. --> inform FDA via a name change at the FDA DRLM website.

The company, or just one or more products, was sold to another company. --> the new owner must list the products at the DRLM website, the old owner must de-list the same products.

The 510(k) itself was sold --> memoes to file by the seller and the buyer.

Just a marketing-name change for the product, no significant change to: sterilization method, structural material, manufacturing method, operating parameters or conditions for use, patient or user safety features, sterile barrier packaging material, stability or expiration claims, design or other factors that might affect safety or effectiveness --> memo to file.
 
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S

Silvertabb

#3
Re: What is the best approach for a Class II Medical Device when its branding changes

This is a product name change. In additional, some graphics on the packaging will be added or changed.
 
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