Hello Anon,
Regulatory submissions are significant for any company including US FDA 510(k)s. The individual(s) making the 510(k) submission needs to have the proper qualifications, experience, and competency for filing the submission. This is assuming from the statements this is a new 510(k) submission for an existing 510(k) cleared product. If they choose to have their Contract Manufacturer complete the update to the 510(k), ensure the contract manufacturer has the knowledge and experience doing this activity. Another option is using a third-party regulatory firm to complete the submission. The individual or entity making the 510(k) submission can be anyone, but the "Submitter" of the 510(k) should be clearly identified as the Manufacturer who is going to "own" the 510(k) submission. What your client wants to make sure is 1) if the contract manufacturer makes the submission, they have all of the source information and 2) if submitted by the contract manufacturer, make sure they are identified as the Submitter (holder of the 510(k)). Because having seen this in the past, the legal company allows another entity like a Contract Manufacturer to submit the 510(k), then they find out later they do not "own" the 510(k) causing problems when changes or departure from the contract manufacturer happens.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 29-Nov-2022 23:51
From: Anonymous Member
Subject: Contract Manufacturer Filing
This message was posted by a user wishing to remain anonymous
I am working with a client who is debating whether or not to have their contact manufacturer file an update to the manufacturers current 510(k) or file the 510(k) themselves for their design. Does anyone have thoughts on pros ad cons of both options? TIA.