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The function of the CDRH Ombudsman parallels that of the FDA Office of the Ombudsman, located in the Office of the FDA Commissioner, but provides an avenue for resolving complaints involving CDRH programs at a level closer to the source. Because the FDA Office of the Ombudsman has agency-wide jurisdiction, it is appropriate to contact that Office when an issue involves more than one FDA center, or at any time when involvement by someone outside CDRH would be useful. The FDA Office of the Ombudsman also determines the appropriate classification and regulatory path for combination products and for drug, device, and biological products when the jurisdiction over a product is unclear or in dispute.
Updated February 5, 2007
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Center for Devices and Radiological Health / CDRH