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§ 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:
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(6) … +
§ 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:
(4) Devia… +
§ 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:
(5) Infor… +
§ 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:
(3) Progr… +
§ 812.150 Reports.
(b) Sponsor reports
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(8) Informed consent. A sponsor shall submit to FDA a copy of any report by an investigator under paragra… +
§ 812.150 Reports.
(b) Sponsor reports.
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(1) Unanticipated adverse device effects. A sponsor who conducts an evaluation of an unanticipated adver… +
§ 812.150 Reports.
(b) Sponsor reports.
[...]
(5) Progress reports. At regular intervals, and at least yearly, a sponsor shall submit progress reports… +
§ 812.150 Reports.
(b) Sponsor reports.
[...]
(7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within 30 worki… +
§ 812.150 Reports.
(b) Sponsor reports.
[...]
(7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within 30 worki… +
§ 812.150 Reports.
(b) Sponsor reports.
[...]
(2) Withdrawal of IRB approval. A sponsor shall notify FDA and all reviewing IRB's and participating inv… +
§ 812.25 Investigational plan.
The investigational plan shall include, in the following order:
(a) Purpose. The name and intended use of the device an… +
§ 812.27 Report of prior investigations.
(a) General. The report of prior investigations shall include reports of all prior clinical, animal, and labo… +
§ 812.30 FDA action on applications
(a) Approval or disapproval. FDA will notify the sponsor in writing of the date it receives an application. FDA ma… +
§ 812.30 FDA action on applications
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(b) Grounds for disapproval or withdrawal. FDA may disapprove or withdraw approval of an application if FDA … +
§ 812.35 Supplemental applications
(a) Changes in investigational plan —
(1) Changes requiring prior approval
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(2) Changes effected for emergency u… +
§ 812.36 Treatment use of an investigational device.
(c) Applications for treatment use.
(1) A treatment IDE application shall include, in the followi… +
§ 812.36 Treatment use of an investigational device.
(a) General. A device that is not approved for marketing may be under clinical investigation for … +
§ 812.40 General responsibilities of sponsors.
Sponsors are responsible for selecting qualified investigators and providing them with the information … +
§ 812.42 FDA and IRB approval.
A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the appl… +
§ 812.43 Selecting investigators and monitors.
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(4) A statement of the investigator's commitment to:
(i) Conduct the investigation in accordance wi… +
