Re-evaluation of an FDA-approved IDE Categorization Decision

20.5 – Re-evaluation of an FDA-approved IDE Categorization Decision (Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15) 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.