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U.S. Department of Health and Human Services

About FDA

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Footnotes

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[1] A Humanitarian Use Device (HUD) designation from OPD is required for a device sponsor prior to applying for a HUD designation from FDA. An Humanitarian Device Exemption (HDE) for a specific device allows the sponsor to bring the device to market for a very small population (usually less than 4,000 people in the U.S.) after demonstrating the safety and probable benefit of the device. The sponsor is exempt from meeting other requirements of the Safe Medical Devices Act.

  1. CVM has implemented a user fee program in FY 2004. Outputs are not expected to increase substantially until new reviewers are hired and fully trained. Performance estimates are dependent upon a sustained level of base and user fee resources. The FY 2005-2006 estimates do not include invited labeling change supplement applications because it is not possible to accurately project sponsor or CVM requests for this type of application.

[2] Includes originals and reactivations. If the application is not approvable, the sponsor may submit additional information until the Agency is able to approve the application.

[3] Reflects submissions (received during the fiscal year) which still require review.

[4] A supplemental application is a sponsor request to change the conditions of the existing approval. They can be significant (a new species or indication), or routine (product manufacturing changes).

[5] An INAD or JINAD file is established at the request of the sponsor to archive all sponsor submissions for a phased drug review including: request for interstate shipment of an unapproved drug for study, protocols, technical sections, data sets, meeting requests, memos of conference and other information.

[6] Non-drug substances added to animal feed are considered Food Additive Petitions and require review and approval.

 

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