Two FDA questions regarding UDI (and potentially 803.52 MDR)

#1
Hi all,

I have two unrelated questions about UDI, and I would say they both come down to interpretation. I'm inclined to reach out to the UDI Help Desk, but I thought I'd see if anyone had any direct experience.

1) According to 803.52(c), a medical device report should contain "(4) Model number, catalog number, serial number, lot number, or other identifying number; expiration date; and unique device identifier (UDI) that appears on the device label or on the device package;" This is also repeated on the Instructions for Use for Field D4 on the MDR Form from the FDA website. This is pretty clearly the "whole" UDI. However, in the downloadable HL7 templates for eMDR, the description of field D4 says "NOTE: Manufacturer and distributor reports should contain the DI only. User Facility reports who cannot parse the DI out of the complete UDI should include the whole human-readable UDI." I don't find that clarification about eMDR anywhere else. Although that note, that's in a spreadsheet on the FDA website, is clear, it doesn't seem to agree with the regulation, which usually trumps informal guidance. Thoughts?

2) We are trying to consider potential impact of having our products of solutions in bags, currently classified as Drugs and regulated by CDER, reclassified as combination products. Presumably they would still be considered part-drug and have CDER as the lead agency, but we're wondering about drug vs. device labeling, and would a UDI be required. Any thoughts here, as well?

Thanks in advance.
 
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