There is a lot of angst in the pharma community right now about the fast approaching DSCSA first deadline for the exchange of transaction data, but the medical device community is dealing with an even earlier deadline: the September 24, 2014 deadline for UDI on class III medical devices.
The FDA UDI web page lists the following requirements for the September deadline, now less than five months away:
- The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.
- Dates on the labels of these devices must be formatted as required by § 801.18.
- Data for these devices must be submitted to the Global Unique Device Identifier Database (GUDID). § 830.300.
- A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.
- Class III stand-alone software must provide its UDI as required by § 801.50(b).
Manufacturers or labelers should be well on their way toward meeting these requirements by now. If not, then be aware of that June 23, 2014 deadline to submit a request for that 1-year extension—but be prepared to supply a good reason.
The steps class III device makers or labelers should take include:
1) Select one of the three FDA-accredited identifier issuing agencies: GS1 US, HIBCC or ICCBBA. Your selection may depend on several things of your own choosing, including which one of these you may already be using for all or some of your products;
2) Apply for the necessary base number from your chosen issuing agency. For GS1 US this would be their Global Company Prefix (GCP), for HIBCC it would be their Labeler Identification Code (LIC), and for ICCBBA it would be your Facility ID Number (FIN);
3) Follow the rules of your chosen issuing agency to assign unique device identifiers to every FDA-registered medical device you label;
4) Make the mandated changes to the product label that you apply to your device and/or packaging, including:
a) Human readable date formatting;
b) UDI device identifier (DI);
c) UDI production identifier(s) (PI);
5) Find the appropriate nomenclature that describes your device in the Global Medical Device Nomenclature (GMDN) database;
6) Obtain your Data Universal Numbering System (DUNS) number(s) from Dun and Bradstreet;
7) Request a GUDID account from the FDA using your DUNS number(s);
8) Build the standardized description of your device following the GUDID database rules and including your GMDN nomenclature;
9) Finally load your device description into the FDA’s GUDID database to “register” your device using the GUDID web interface or HL7 Structured Product Labeling (SPL) using the FDA Electronic Submissions Gateway.
If you are a class III device manufacturer or labeler and you have not yet started this process, you had better get some help from a qualified consulting company who has done this before. One way to come up to speed quickly and get all your questions answered is to attend the UDI Workshop on May 20-22, 2014 in Baltimore (see “Bringing UDI and the Global UDI Database to Life“).
If you plan to attend, use the “promotion code” “RX” to get a special $100 RxTrace discount off the registration price. The promotion code will also work for the UDI Conference in October, but that will be too late for class III device makers who have not been granted an extension.