SPL (Structured Product Labeling) is an XML format specified by the HL7 SPL working group and formally supported by the FDA (Food and Drug Administration).
The FDA requires all drug product content of labeling, establishment and registration information to be submitted in the SPL format. This initiative was recently extended to include Medical Device products as well. You can read more about the latest SPL Guidance updates here.
Since 2004, i4i has been a key member of the SPL Working Group, where we have used our XML knowledge and
industry expertise to support the FDA’s SPL initiative. We remain committed to delivering comprehensive and easy-to-use
authoring and content management solutions, that are first to market and best-in-class to comply with FDA standards.