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Tips For Completing Applications

To ensure legibility and accuracy, please complete all fields electronically before printing and signing the application.

Section A – Submitter Identification
If someone other than the person who signs the application in Section E needs to receive all correspondence related to the application, please put this person's name in the top part of Section A.

Section B – Marketing Information
All PDAC coding verification applications must contain either a copy of the FDA 510K Summary Letter or a copy of the Establishment Registration & Device Listing.

For information on obtaining a 510(K) number, please visit the FDA Web site at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm.

For information on the Establishment Registration & Device Listing, visit the FDA website at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm.

Section B asks for the HCPCS code that best meets the description of the product. This is not required information, but it is helpful to include. The following steps will assist in finding a HCPCS code for the product:

NOTE: Only one HCPCS code can be submitted on each HCPCS Coding Verification application, unless the additional HCPCS code(s) are the base code add-ons/accessory code(s).

Section D – Product Listing on DMECS
Please review this section carefully to ensure your product is listed correctly on the Product Classification List (PCL) within the Durable Medical Equipment Coding System (DMECS) after the code is assigned.

This section can be copied multiple times to allow the submission of more than 5 model numbers on one application.

Multiple model numbers can be submitted on the same application only if the request is for the same base HCPCS code and any respective add-on / accessory code(s).

Section E – Authorized Official Signature
There must be an original signature on the application. The additional signature is only required if the application is completed by a distributor for a manufacturer’s product, or if there are multiple company names listed in the Manufacturer and/or Distributor name field in Section D.

Information to submit with the application
Please include current and original marketing literature with each application. Copies will not be accepted. If the item product being submitted for coding verification is pre-market, please note the required information in Section B.