1 Structured Product Labeling Project Update Randy Levin, M.D. Director for Health and Regulatory Data Standards Food and Drug Administration HL7 Working Group meeting September 18, 2007

2 Project Scope Device identification Differentiating product characteristics Veterinary medicine and other listing information Billing units

3 Device Identification Available –Unique device identifier –Manufacturer –Quantity –Market approval number –Indication –Ingredient –Device type –Characteristics – allergens, Single use or reusable (and number of times), accessory New –Identifying numbers – Model number, software version, serial number, lot number –Expiration date –Significant product modifications –Device configuration

4 Other Additions Differentiating characteristics –Available Product differentiating characteristics (freeness, flavors, allergens, metabolic intolerances) Veterinary medicine and other listing information –Available Original text for dosage form Proprietary name suffix Original text for strength Clinical drug (e.g., RxNorm) –New Basis of strength Therapeutic equivalent Billing units

5 Model Changes