FDA Extends UDI Deadline to October

The FDA has extended the deadline for getting compliant with the new Unique Device Identification (UDI) system until October 24, 2015.

According to an August 14, 2015 agency guidance, the deadline was moved back one month due to undisclosed “security vulnerabilities” when the agency’s Global Unique Device Identification Database (GUDID) was taken offline on August 7, 2015.

The new deadline also applies to Class III devices whose manufacturers have filed for and obtained compliance extensions that expire between August 7 and September 24, 2015.

The FDA issued regulations in September 2013 establishing the UDI system and gave companies until September 2015 to comply with the labeling and data submissions. But the security “vulnerability” caused the agency to take system offline while a patch is being implemented.

UDI Requirements

According to Stewart Eisenhart of the Emergo Group, complying with UDI requirements involves more than just etching a number onto a medical device or adding a bar code to a label. Several components are involved:

Each UDI must can two numbers: a device identifier and a production identifier. A device identifier must correspond to the specific model or version of a medical device and the company name. A production identifier must provide a medical device’s lot or batch information or serial number, expiration date and related production data.

• Class I devices must be assigned device identifiers only. Class II and III devices must be assigned both device identifiers and product identifiers.
• Manufacturers must obtain UDI numbers only from FDA-accredited issuing agencies.
• All medical devices registered for sale in the US will have to include UDI information on their labeling and packaging.
• Devices intended for more than one use as well as devices requiring reprocessing before each use must also have UDI data marked directly on them.
• Manufacturers must provide UDI information in both plain-text (human readable) and AIDC (Automatic Identification and Capture) formats.

Manufacturers will be required to submit UDI data into a new FDA database, the Global Unique Device Identification Database (GUDID) using proper formatting.

To read the FDA guidance document, click here.