§ 812.66 - Significant risk device determinations.

Latest version.

§ 812.66 Significant risk device determinations.

If an IRB determines that an investigation, presented for approval under § 812.2(b)(1)(ii), involves a significant risk device, it shall so notify the investigator and, where appropriate, the sponsor. A sponsor may not begin the investigation except as provided in § 812.30(a).

[46 FR 8957, Jan. 27, 1981]

                    
                        var val = document.getElementById('citecontent').innerHTML;
                        art.dialog.defaults.title = window.location.href;
                        art.dialog.data('cite', val);
                        art.dialog.data('homeDemoPath', '/Scripts/plus/artDialog/');
                        art.dialog.open('/Scripts/plus/artDialog/citeiframe.html');

§ 812.66 - Significant risk device determinations.

§ 812.66 Significant risk device determinations.