As medical device manufacturers delve more deeply into the requirements for compliance with the FDA final rule on Unique Device Identification, many find they have to revise internal processes or seek outside assistance to meet UDI labeling and Global Unique Device Identifier Database submission requirements. One such issue to consider as a manufacturer is whether or not to employ SPL, or Structured Product Labeling, as your submission method to the GUDID.
Many medical device manufacturers are unfamiliar with SPL, assuming it is a standard that only large corporations need to implement. They may not realize that converting medical device data into SPL holds benefits for device manufacturers of all sizes.
What is SPL?
The electronic data submission requirements with which medical device manufacturers now must comply were first applied to the pharmaceutical industry. The FDA requires makers of drug and biologic products to electronically submit their Content of Labeling, also known as package insert content or USPI, to an FDA database.
Beginning in 2005, the FDA adopted SPL as the designated electronic format for drug labeling submissions. SPL is a document authoring standard in eXtensible Markup Language (XML). Initially developed by Health Level Seven (HL7), an independent, international provider of healthcare standards, SPL allows data to be easily searched and shared between various computer systems to support ongoing electronic health initiatives.
In the last ten years, the FDA has adopted the SPL standard for additional submission types, including electronic drug listing, drug establishment registration, NDC labeler code requests and, now, medical device UDI submissions.
What does SPL mean for Medical Device Manufacturers?
The FDA’s final UDI rule for the medical device industry offered device manufacturers two ways to submit the required data to the FDA. The first option requires manually inputting the product information, record by record, into the FDA’s Web Interface. The second option is to convert “raw” product data into SPL format, enabling the manufacturer to submit in bulk through the Electronic Submissions Gateway (ESG).
As many device manufacturers learned during the process leading up to the first submission deadline for Class III devices of Sept. 24, 2014, submitting data through the GUDID Web Interface can be time-consuming. The required investment of time and resources grows in proportion to the size of a company’s product portfolio. Some manufacturers with only a handful of Class III medical devices were able to use the GUDID Web Interface efficiently. Now, however, they may face submission requirements for thousands, or even tens of thousands, of Class II and Class I devices.
Thus, for many device manufacturers, SPL conversion in preparation for electronic submission will be a more cost-effective, efficient, and accurate option.
Reed Tech has ten years of experience in SPL conversion services. Our experience with SPL and understanding of FDA regulations and dynamics offers you an unparalleled depth of knowledge and submission accuracy. To learn more about SPL conversion and whether it is right for your company, call or email Haley Lentz: +1-215-441-6493, HLentz@ReedTech.com.