Since June 2009, all drug listing submissions have been done electronically using Structured Product Labeling (SPL) files. Now, devices can be listed using SPL as well. While the FDA does not require that devices be listed using SPL, the ability to do is there, with benefits including providing product exposure on sites such as the National of Library of Medicine’s (NLM) DailyMed.
These files can be created in many different ways, using software such as the FDA’s XForm application, commercial SPL applications, XML tools, and text editors, or outsourcing to companies that provide the service. However, only one type of file should be output: a file with accurate information for the device or drug product and its packaging, the companies involved in manufacturing the device or drug (from the Active Pharmaceutical Ingredient (API) to the packaging and labeling of the products), and the content of labeling (label on the box or the package insert).
This article presents best practices in preparing the files, and a look at common pitfalls companies face in doing so.
Now, on to what information is needed for the SPL! To add to the information found in this article, please refer to the FDA's SPL Resources page and to the SPL Working Group (WG, a group of pharmaceutical companies, conversion vendors, and the FDA) Wiki . If you are a do-it-yourselfer but require some assistance, you may contact the FDA at email@example.com (that’s the SPL group for technical questions and training).
Please note: the upcoming Unique Device Identifier (UDI) for devices is not discussed here because final guidance has not yet been released. For those not already familiar with UDI, please refer to the FDA’s press release of a year ago, including a link to the proposed rule.
The first piece of information in the SPL is the document type, which can be found on the FDA’s SPL Resources page by clicking on Document Type. There are document types for devices, and for drugs. When the product is exclusively a device (no drug is in it) the document type is one of the medical device documents (such as prescription medical device label or OTC medical device label); when it is a combination of device and drug, there is a selection of appropriate drug submission document types.
The labeler is the distributor of the product, meaning that the product sold by the distributor needs to have a National Drug Code (NDC )that uses the distributor’s – not the manufacturer’s – labeler code. This wasn’t always common industry practice in the past, but is now required.
A common mistake made when assigning labeler information is using the wrong Data Universal Numbering System (DUNS) Number. A labeler may have multiple DUNS Numbers but the labeler code is assigned to only one of them. Be sure you use the DUNS Number to which the labeler code is assigned, otherwise a validation error will result. If you’re not sure which DUNS Number was used, check with the FDA’s Electronic Drug Registration and Listing System (EDRLS) group at firstname.lastname@example.org.
Both existing unassigned labeler codes (assigned by the FDA prior to June 2009 and not registered using SPL) and newly assigned labeler codes (requested using SPL and assigned by the FDA) need to be registered using SPL. Submit an NDC Labeler Code file with the labeler code that was assigned.
Distributors who need labeler codes request them using SPL. Please note, the process of obtaining a labeler code is not completed until the labeler successfully submits the NDC labeler code file with the assigned labeler code. In other words, a device label usually needs an NDC. The first part of an NDC is the labeler code, the NDC can’t be created without it; the rest of the NDC is assigned by the company.
Assigned labeler codes can be verified by a link on FDA’s SPL Resources page, click on NDC/NHRIC Labeler Codes in the Data Standards column.
Best practice here is to complete this section only if you are a manufacturer completing the form for a private label distributor. That’s what the FDA intended it for; see the FDA Step-by-Step Instructions on the SPL Resources page.
Much of the information need for the device is straightforward, such as the proprietary name, NDC code, and packaging information. Among other information needed are:
- Product classification/device type and its code, found in the FDA’s Product Classification Database. If you cannot find your device there please contact Lonnie Smith of the FDA at email@example.com.
- Also include any of the following if applicable to your device, indicating what type of number it is:
- Model number
- Catalog number
- Each reference number
- Start marketing date for the device. Note that this is the date the label is made available to the public, so be sure to use an appropriate date.
- Marketing category – There are several to choose from for devices, such as Premarket Notification or Exempt Device, be sure to use the correct one, along with it’s number, such as K123456 for premarket notification.
There are additional items of information that can be coded, with others on the way. See the FDA’s SPL Implementation Guide with Validation Procedures, available through the SPL Resources page. Currently Sections 3.3and 11 have information specific to devices.
Content of Labeling
When you have contact labeling, such as a package insert, include it in the label. The text should be broken into sections that include the appropriate Logical Observation and Identifier Names and Codes (LOINCs) to identify the type of content in the section. The Section Headings (LOINC) link under Data Standards on the SPL Resources page lists the LOINCs available; using the appropriate ones for the sections is important in clinical decisions support system and in how individuals search labels.
Principal Display Panel and Package Images
As with all listing submissions you need to provide at least one section with an image of a package label. Best practices here are to include the principal display panel (PDP) text as text in the section and Use images that fit on a normal sized monitor without scrolling across and that are legible; use multiple images if needed
In an SPL listing, submission information is provided on the sites involved in manufacturing the drug(s) and devices being listed. The only information you provide for each submission is the DUNS Number and company name and the operation(s) done at the site. The establishment must have already registered as a site, specifying its operations.
Before submission you can verify the site is currently registered with the FDA, and what DUNS Number it is registered with, by going to the FDA’s Drug Establishment Current Registration Status (DECRS, formerly DFARS) site. I recommend you enter only a few letters of the company name, rather than the whole name, to avoid missing the site because of differences between the name you entered and the name it is listed with. The operations it is registered for are not publicly available; contact the company or the FDA if there is an issue with the operations specified.
For more information, visit www.dclab.com.