Common use of Study Device Clause in Contracts

Study Device. The Study Device shall only be used as described in the applicable Protocol and in compliance with Applicable Laws, including those pertaining to Investigational Device Exemptions. The parties acknowledge that the Study Device has not been cleared or approved by the FDA for the indication under investigation in the Study. SPONSOR is the regulatory sponsor for the Study and agrees that it has complied with all applicable laws and regulations, including filing of any required Investigational Device Exemption. The Institution shall maintain complete and accurate records relating to the storage, inventory, and disposition of the Study Device supplied to the Institution, as set forth in Section 11.1.

Study Device. The Study Device shall only be used as described in the applicable Protocol and in compliance with Applicable Laws, including those pertaining to Investigational Device Exemptions. The parties acknowledge that the Study Device has not been cleared or approved by the FDA for the indication under investigation in the Study. SPONSOR is the regulatory sponsor for the Study and agrees represents and warrants that it has complied with all applicable laws and regulations, including filing of any required Investigational Device ExemptionExemption and receiving due authorization prior to commencement of the Study. The Institution shall maintain complete and accurate records relating to the storage, inventory, and disposition of the Study Device supplied to the Institution, as set forth in Section 11.1.