Section 226 of the FDA Amendments Act (FDAAA) of 2007 and Section 614 of the FDA Safety and Innovation Act (FDASIA) of 2012 amended the Federal Food, Drug and Cosmetic Act to add section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices along with implementation timeframes for certain medical devices. The Unique Device Identifier (UDI) Proposed Rule was published on July 10, 2012. The UDI Final Rule was published on September 24, 2013.
The objectives of the UDI Program are to:
- Facilitate the rapid and accurate identification of a device
- Enable access to important information concerning the device
- Allow more accurate reportin, reviewing and analyzing of adverse even reports
- Provide a standard and clear way to document device use in electronic health records, clinical information systems, claims data sources and registries
- Enable more effectively managed medical device recalls
A UDI is a code on the device label, packaging or, in some cases, on the device itself. This code is captured in both plain text and machine readable format (barcode). For Class II devices (which biological indicators are a part of), the implementation date for the UDI label and Global Unique Device Identification Database (GUDID) registration is September 24, 2016.
From the time of the ruling, Mesa Labs’ Biological Indicator Division has been making strides to have the required UDI codes in place in early 2016. Information was gathered, and it was agreed that the UDI would not be required on each unit but would be captured in the outer packaging label for 510(k) products.
On June 26, 2015 the FDA released a draft guidance document, “Unique Device Identification: Direct Marking of Devices”. There are two excerpts from this guidance document that made us re-evaluate whether biological indicators needed to comply with this ruling:
“21 CFR 801.45 requires a device bear a permanent UDI marking if the device is intended to be used more than once and intended to be reprocessed before each use.”
“…UDI direct marking requirements apply to devices that are intended to be used for months or years, sometimes many years. Because such devices are intended to be reprocessed and reused, they will inevitably be separated from their original labels and device packages.”
Upon discussion with upper management, Mesa Labs’ BI Division has decided that a Unique Device Identifier is not required for biological indicators.