Hello Anon,
My comment would be a simple answer yes, the previous/old establishment registration for the site should be kept in the FURLS database until the last product is manufactured and released from the facility. A distributor does not have any relevancy in this scenario. I am not sure I am following the last question.
When a Contract Manufacturer (FDA's term - assuming this is the case using your terminology of subcontracted finished device) changes manufacturing site there is flexibility in the FURLS database for this. There is an Owner/Operator which would be the "main" company or login. Under the Owner/Operator, can then list the different establishments, so during some period of time there would be the previous/old establishment and the new establishment under the same Owner/Operator.
I would like to add a further comment, create an internal Quality Plan which describes how this is being done and managed, including responsibilities and timelines. This might be important in the future during a potential FDA inspection showing when production started at the new facility and finished at the old facility. The investigator would not want any surprises reviewing some process and realising this was actually not done at the new facility, but done a year or more ago at the old facility. It can just help prevent some potential discussions.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-May-2023 13:23
From: Kevin Randall
Subject: Establishment Registration after a Medical Device is transferred
Having previously worked through such scenarios for the U.S. FDA medical device jurisdiction, my experience has been that this represents a particular FDA regulatory nebula. Specifically, establishment registration is required if a firm is engaged in the propagation (among other activities) and commercial distribution of devices intended for human use, yet such establishment registration isn't required of wholesale distributors [any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user. Having previously attempted to get insights from the FDA about this dichotomy, FDA has declined to give me definitive interpretive direction, except for to recite the aforesaid regulatory concepts and then say that the agency doesn't make such legal determinations for firms. But this of course doesn't preclude FDA from taking a legal position later if the agency subsequently disagrees with a firm's approach.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 10-May-2023 15:59
From: Anonymous Member
Subject: Establishment Registration after a Medical Device is transferred
This message was posted by a user wishing to remain anonymous
Hi All,
I'm looking to understand a little bit more if an establishment needs to be registered after a subcontracted finished medical device is transferred to a new site. I understand that the new site will be registered but should I keep the registration of the old site until the last units manufactured are distributed or can we delist from the old facility? Do we need to be the distributor? Or should I transfer ownership even though we are subcontracted manufacturer?
Thanks in advance!<o:p></o:p>