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  1. FDA Resources for Data Standards

Regulated Product Submission

Regulated Product Submission Release 1 (RPS) is a Health Level Seven (HL7) standard to facilitate the processing and review of regulated product information. 

Release 1 was approved as an ANSI standard in 2008.

Release 2 is currently being developed at HL7 and expands on release one to include two way communication and information about the submission. 

Resources

For all RPS information go to: http://wiki.hl7.org/index.php?title=Regulated_Product_Submissions

FDA Data Exchange Standards Initiatives - Regulated Product Submission (RPS) Standard Status(PDF) 

Contact Information

Questions regarding the Regulated Product Submission should directed to:

Peggy Leizear