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Product Sample Requirements

A sample product must be included with the Code Verification Review Application for certain DMEPOS products. For applications submitted on/after July 9, 2018, the product sample requirements are as follows:

Coding verification applications with product samples that do not meet these requirements are considered incomplete and cannot be reviewed by the PDAC. Incomplete applications will not be processed. Manufacturers may resubmit the application with an appropriate sample.

NOTE: Product labeling requirements specified in a DME MAC Local Coverage Determination (LCD) or article, supersede these product sample requirements.

Unless otherwise noted in the Code Verification Review Application, send only one sample.

Product samples are not routinely returned. To request the return of a product sample, include a written request and a paid return label with your application. Samples will be returned after the CMS required retention period expires.

View the below related information on this page.

Required Product Samples

Samples are required for the following products:

Not Required Product Samples

Product samples are not required for the following products.

Do not send samples of these items unless specifically requested by the PDAC.

NOTE: The above lists are subject to change. If a product is not listed, review the Code Verification Review Application for instructions, call the PDAC Contact Center, or email us.

Updated September 2018