§812.36. Treatment use of an investigational device. — Inbound Citations
21 C.F.R. § 812.36
Statutory Authority
Cited by 3 regulations in release Current.
Citations to §812.36(b)
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(i) The criteria specified in § 812.36(b) are not met or the treatment IDE does not contain the information required in § 812.36(c);
Citations to §812.36(c)
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(i) The criteria specified in § 812.36(b) are not met or the treatment IDE does not contain the information required in § 812.36(c);
Citations to §812.36(f)
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(5) At regular intervals, and at least yearly, a sponsor shall submit progress reports to all reviewing IRB's. In the case of a significant risk device, a sponsor shall also submit progress reports to FDA. A sponsor of a treatment IDE shall submit semi-annual progress reports to all reviewing IRB's and FDA in accordance with § 812.36(f) and annual reports in accordance with this section.