Investigational Device Exemption Requirements Sample Clauses

Investigational Device Exemption Requirements. Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE). Exceptions must be granted in writing by FDA. If the proposed clinical trial will be performed under an IDE, the Contractor must provide BARDA with the name and institution of the IDE sponsor, the date the or IDE was filed with FDA, the FDA or IDE number, any written comments from FDA, and the written responses to those comments. Unless FDA notifies Contractor otherwise, The Contractor must wait thirty [***] from FDA receipt of an initial or IDE application before initiating a clinical trial. The Contractor must notify BARDA if the FDA places the study on clinical hold and provide BARDA any written comments from FDA, written responses to the comments, and documentation in writing that the hold has been lifted. The Contractor must not use grant or contract funds during a clinical hold to fund clinical studies that are on hold. The Contractor must not enter into any new financial obligations related to clinical activities for the clinical trial on clinical hold.
Sample 1
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Related to Investigational Device Exemption Requirements

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  • Information Requirement The successful bidder's shall be required to advise the Office of Management and Budget, Government Support Services of the gross amount of purchases made as a result of the contract.

  • Notification Requirement Through and up to the conclusion of the Non-Competition Period, Executive shall give notice to the Company of each new business activity he plans to undertake, at least seven (7) days prior to beginning any such activity. Such notice shall state the name and address of the Person for whom such activity is undertaken and the nature of Executive’s business relationship(s) and position(s) with such Person.

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