Re: Definition of "Legal Manufacturer"
How can you satisfy the MDD and the FDA at the same time with the same label for the following issue?
Our company is revising our labeling and top mgmt feels we should stated "Manufactured for XYZ" because XYZ is not registered as a manufacturer with the FDA (only a repackager/relabeler). However we apply the CE mark so this means the label should stated "Manufactured by XYZ".
Would it resolve everything if I used the Manufacturer symbol from EN 980?
Not a good idea for four reasons:
1. I assume your product is not an IVD. Some elements of FDA recognize that symbol's EN 980 meaning for applications other than IVDs, even though the applicable FDA guidance states that that's the extent of its recognition. So, such a use would have the potential to cause confusion within FDA.
2. I gather that you want to use a single label for all markets. Clearly the presence of the EN 980 "Manufactured By" symbol would have the potential to cause confusion among your US customers, at least some of whom probably are familiar with European labeling approaches. More importantly, an English-text "Manufactured For" on the same label statement will be a nonstarter in Euro markets for multiple reasons.
3. The FDA is moving toward harmonization, most particularly in regard to this Fall's scheduled Voluntary Audit Submission Program startup, which will recognize ISO 13485 QMS conformance as sufficient evidence of no need for QSIT 1 inspection exposure. That change in particular is likely to initiate quicker moves toward integration on the labeling side. There's no margin in setting a path now that will be inadequate again in just a few months.
4. Maybe this applies, maybe not: will the actual maker List your product as its Manufacturer if you declare yourself to not be the Manufacturer? Every medical device must have a Manufacturer. If you label as if you're not the Manufacturer, but the actual maker can convincingly show that they should not be regarded as the regulatorily responsible Manufacturer, the FDA can come back to you and determine that the product is adulterated because your labeling illegally disclaims responsibility for a device for which they regard you as responsible.
Why don't you just List the product as its Manufacturer with US FDA, and be done with it? Your cost won't change, your legal exposure won't change, and it takes ten minutes. What's the reason why that's not the obvious course?