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FDA Document Request – Dignicap Clinical Use Protocols
FDA Document Request – Dignicap Clinical Use Protocols
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Original Request: Please provide information regarding Dignicap and Dignicap Delta Research supporting its use in clinical settings during chemo therapy FDA clearance Protocol for use in the clinical settings Required credentials and training of clinical staff who place, manage, set, and monitor Dignicap and Deignicap Delta Protocol and criteria for altering standard level settings set by the manufacturer along with criteria that warrants lowering the standard level of Dignicap settings
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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