Medical device manufacturers working to comply with the FDA’s Unique Device Identification mandate have more than one set of regulations to keep in mind. Fortunately, some of the regulations have been in place for some time and will be at least somewhat familiar to life sciences companies.
Many readers will already be familiar with 21 CFR Part 11, the set of federal regulations that govern electronic records and require strict accountability around access and changes to databases and other electronic resources involved in the production of regulated products. UDI compliance is no exception.
If you are submitting device data to the FDA’s GUDID database in Structured Product Labeling (SPL) format, you must also ensure that your submission process is 21 CFR Part 11 compliant.
You should be aware of which Subparts are a priority to the FDA, which Subparts are subject to enforcement discretion, and that Subpart C pertaining just to eSignatures is specifically exempt from SPL submissions. The labeler is legally responsible for conformance and should require 21 CFR Part 11 documentation from any vendor or associated entity involved in a UDI compliance project.
Software alone is not the solution
UDI regulations require software used in managing electronic records for design, production, and GUDID submission must conform to 21 CFR Part 11.
That said, 21 CFR Part 11 compliance cannot be incorporated into a UDI project exclusively through software. It requires a set of organizational policies and procedures that may already exist in some form at the organization, but which may need revision or amendment in order to ensure that UDI compliance efforts also meet the regulations. An experienced UDI submission partner can offer guidance on the points related to UDI record submissions.
If you have questions about UDI submissions and 21 CFR Part 11 compliance, other UDI questions, we welcome you to contact the experts at Reed Tech.