CMS Pub. 100-02, ch. 14, § 20.5

Any sponsor (i.e., manufacturer) that does not agree with the FDA decision that

categorizes its device as Category A may submit a written request asking the FDA to

reevaluate its categorization decision. The sponsor (i.e., a manufacturer) may send a

written request to the FDA at any time asking for a reevaluation of its original

categorization decision, submitting any additional evidence and information which it

believes supports a re-categorization. The FDA notifies both CMS and the sponsor (i.e.,

manufacturer) of its reevaluation decision.

If the FDA reconfirms its original decision on the categorization of the device, the

sponsor (e.g., a manufacturer) may seek a review by the CMS Central Office. The device

sponsor (e.g., a manufacturer) must submit its request in writing, and must include all

materials submitted with its reevaluation request to the FDA. Review requests must be

addressed to:

Centers for Medicare & Medicaid Services

Attn: IDE Categorization Review

Mail Stop: S3-02-01

Coverage and Analysis Group,

Center for Clinical Standards and Quality,

7500 Security Blvd.

Baltimore, MD 21244-1850

The CMS staff will review this information to determine whether to change the

categorization of the device and will issue a written decision notifying both the device

sponsor (e.g., a manufacturer) and the FDA of its decision. In evaluating a

manufacturer’s request for re-categorization, CMS will review only that information

submitted to the FDA. Information not submitted to the FDA for its consideration will

not be reviewed by CMS.

To the extent that CMS relies on confidential commercial or trade secret information in

any judicial proceeding, CMS will maintain confidentiality of the information in

accordance with Federal law.

No reviews of a categorization decision other than those described above are available to

a sponsor (e.g., a manufacturer). Neither the FDA original categorization decision or

reevaluation, nor CMS’ review constitutes an initial determination for purposes of the

Medicare appeals processes under part 405, subpart G or subpart H or parts 417, 473,

or 498 of title 42 of the Code of Federal Regulations.