Hello,
Only changing the company name would not trigger a new 510(k) submission required. With that said, if there are other aspects changing because of the company name change, such as the legal manufacturer being different through a merger or acquisition, then the establishment registration and/or medical device listing may need to be updated. Typically if the name of the company changes on the original 510(k) for whatever reason: marketing needs, acquisition, merger, then would recommend just sending an information letter to FDA CDRH advising them of the change. It is helpful so if a new 510(k) is needed at some point in the future, there can be an explanation and reference back to the information letter submitted previously to prevent confusion or mis-understanding.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 02-Sep-2020 11:52
From: Meenakshi Verma
Subject: Change of name of company impact on 510k
Hi,
Example on Page 64 of the FDA guidance (https://www.fda.gov/media/99812/download) provides some insight.
Important is to evaluate all the changes which may apply.
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Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
Original Message:
Sent: 02-Sep-2020 03:04
From: Anonymous Member
Subject: Change of name of company impact on 510k
This message was posted by a user wishing to remain anonymous
Is a USFDA notification or approval required for company name change after 510K is cleared? Company name on 510k is now changed.