ACE PGA Required Data Elements and Values for …

1 ACE PGA Required data Elements and Values for Medical Devices Program Will always be DEV Process: Please indicate on of the following selections RED - Radiation Emitting Devices NED - Non-Radiation Emitting Devices Description Should be the description as per the Commercial Invoice Intended Use: Must be populated with one of the below codes Sub-Code Description For Human Medical Use as a Medical Device For Human Medical Use as a Medical Device for Domestic Refurbishing For Human Medical Use as Medical Device domestically manufactured which is part of a medical device convenience kit For Human Medical Use as a Medical Device foreign manufactured device that is part of a medical device convenience kit Importation of a device constituent part (finished device) for use in a medical product regulated under a drug (CDER) application type ( , for use in an NDA/ANDA/BLA drug-device combination product).

2 For Personal Use as a Non-Food Product for personal use as a medical device Sub-Code Description For Public Exhibition or Display as a Non-Food Product For Charitable Organization Use as a Non-Food Product Component for further manufacturing into a finished medical device Importation of a device component for use in a medical product regulated under a drug (CDER) application type ( , for use in an NDA/ANDA/BLA drug - device combination product). For Repair of a Non-Food Product For Research and Development as a Non-Food Product - For research and development as a medical device For Research and Development as a Non-Food Product for bench testing or nonclinical research use For Research and Development as a Non-Food Product.

3 Import of a medical device for clinical investigational use Import of a device that is US goods for refund/overstock (to manufacturer) Import of a device that is US goods returned for sale to a third party Import of a Compassionate Use/Emergency Use Device Import of a single-use device for domestic reprocessing Import of a multi-use device for domestic reprocessing Import for Export Product Code Must enter FDA product code (Ex: 89I--PS) Constituent Element (CE) Will remain blank Qty of CE Will remain blank UOM of CE Will remain blank Percent Will remains blank Active Will remain blank ISO Produce (Manufacturer/Grower) ISO Country Code for the country the product was produced (Ex: JP for Japan) For a complete ISO Country Code List, click here ISO Source (Shipping Country) ISO Country Code for the country the product exported from *Note: ISO Source should remain blank if you are entering the ISO Produce.

4 Only enter the ISO Source if the ISO Produce is unknown. Previously Refused ISO If the cargo was previously refused from another country, this field must be populated with an ISO Country code. Trade/Brand Name Must be entered (Ex: Zimmer Reusable Tourniquet Cuff) Character Description Should be the description as per the Commercial Inv. Full Quantity Breakdown Provide packaging and quantity for the item (Ex: 6 Cartons, each carton contains 4 Boxes, each box contains 4 Pieces) Can Dimensions Will remain blank Anticipated Arrival Date Enter the arrival date and time (should default from file data ) Time System should default to 08:00 Location System should default port of entry PGA Line value The value associated with the PGA commodity * Must be in Whole dollars Entities Required Role Code Description MF Manufacturer of Goods DEQ Shipper FD1 FDA Importer (Importer of Record) DII Device Initial Importer DP Delivered to Party (US party that physically receives the goods)

5 List of Affirmation of Compliance Codes Code Description PM# Device Premarket Number For more information on PM#, Click Here DDM Device Domestic Manufacturer For more information on DDM, Click Here DEV Device Foreign Manufacturer Registration Number For more information on DEV, Click Here DFE Device Foreign Exporter Registration Number For more information on DFE, Click Here DI Device Identifier CPT Component Identifier IFE Import For Export IDE Investigational Device Exemption Number For more information on IDE, Click Here IRC Device Impact Resistance Lens Certification For more information on IRC, Click here KIT Device Imported Kit of Finished Device For more information on KIT, Click here LST Device Listing Number For more information on LST, Click here LWC Electrode Lead Wire Or Patient Cable For more informaton on LWC, click here *Note: Affirmation code requirements change based on the intended use of the device.

6 See below Chart of Required AOC s based on use statement: Intended Use Import Scenario Mandatory Affirmations Conditional Affirmations *Standard import of device, accessories, or components regulated as a finished device *Import of refurbished device *Import of a reprocessed device DEV, DFE, LST DI, IRC, LWC, PM# * Import of a device for domestic refurbishing DEV, DFE, LST DI, IRC, LWC, PM# Domestically manufactured device that is part of a medical device Convenience kit DDM, DFE, KIT, LST DI, IRC, LWC, PM# foreign manufactured device that is Part of a medical KIT, DEV, DFE, LST PM#, DI, LWC;IRC device Convenience kit Device constituent part for drug-device combination product DEV, DFE, LST DA Import of a device for charity DEV, DFE, LST DI, IRC, LWC, PM# Component for further manufacturing into a finished medical device CPT LST, PM# Device component for use in a drug-device combination product CPT DA Repair of medical device and re-exportation DDM, IFE DFE, DI, LST, IRC, LWC, PM# * Import of a medical device for clinical investigational use IDE Import of a device that is US goods returned for refund/overstock (to manufacturer)

7 DDM, LST DFE, DI, IRC, LWC, PM# * Import of device that is US goods returned for sale to a third party DFE, DDM, LST DI, IRC, LWC, PM# * Import of a single-use device for domestic reprocessing DDM, LST DFE, DI, IRC, LWC, PM# * Import of a multi-use device for domestic reprocessing DDM, DFE, DI, IRC, LST, LWC, PM# Import for Export: *Import of a medical device for further processing and re-exportation *Importation of a medical device components for further manufacturing into an export-only medical device DEV, DFE, IFE, LST *Note: The below Intended Uses for Medical Devices do not require the filing of Any AOC s: The conditional affirmations are Required if applicable to the product being declared.

8 For example, if the product requires premarket clearance (510(k)), then PM# must be provided. *Annotates that additional information may be needed at time of entry in order for FDA to make a final admissibility decision. Should you have any question, concerns or simply wish to discuss this new requirement please feel free to email with your inquiry. Otherwise please feel free to contact your Customer Service Representative, Sales Person or your usual contact party.