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| [Code of Federal Regulations] |
| [Title 21, Volume 8] |
| [CITE: 21CFR812] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
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| PART 812 | INVESTIGATIONAL DEVICE EXEMPTIONS |
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Subpart C - Responsibilities of Sponsors
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Sec. 812.40 General responsibilities of sponsors.
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Sponsors are responsible for selecting qualified investigators and providing them with the information they need to conduct the investigation properly, ensuring proper monitoring of the investigation, ensuring that IRB review and approval are obtained, submitting an IDE application to FDA, and ensuring that any reviewing IRB and FDA are promptly informed of significant new information about an investigation. Additional responsibilities of sponsors are described in subparts B and G.
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Sec. 812.42 FDA and IRB approval.
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A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation.
[46 FR 8957, Jan. 27, 1981]
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Sec. 812.43 Selecting investigators and monitors.
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(a) Selecting investigators. A sponsor shall select investigators qualified by training and experience to investigate the device.
(b) Control of device. A sponsor shall ship investigational devices only to qualified investigators participating in the investigation.
(c) Obtaining agreements. A sponsor shall obtain from each participating investigator a signed agreement that includes:
(1) The investigator's curriculum vitae.
(2) Where applicable, a statement of the investigator's relevant experience, including the dates, location, extent, and type of experience.
(3) If the investigator was involved in an investigation or other research that was terminated, an explanation of the circumstances that led to termination.
(4) A statement of the investigator's commitment to:
(i) Conduct the investigation in accordance with the agreement, the investigational plan, this part and other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB or FDA;
(ii) Supervise all testing of the device involving human subjects; and
(iii) Ensure that the requirements for obtaining informed consent are met.
(5) Sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement as required under part 54 of this chapter. The sponsor shall obtain a commitment from the clinical investigator to promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following completion of the study. This information shall not be submitted in an investigational device exemption application, but shall be submitted in any marketing application involving the device.
(d) Selecting monitors. A sponsor shall select monitors qualified by training and experience to monitor the investigational study in accordance with this part and other applicable FDA regulations.
[45 FR 3751, Jan. 18, 1980, as amended at 63 FR 5253, Feb. 2, 1998]
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Sec. 812.45 Informing investigators.
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A sponsor shall supply all investigators participating in the investigation with copies of the investigational plan and the report of prior investigations of the device.
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Sec. 812.46 Monitoring investigations.
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(a) Securing compliance. A sponsor who discovers that an investigator is not complying with the signed agreement, the investigational plan, the requirements of this part or other applicable FDA regulations, or any conditions of approval imposed by the reviewing IRB or FDA shall promptly either secure compliance, or discontinue shipments of the device to the investigator and terminate the investigator's participation in the investigation. A sponsor shall also require such an investigator to dispose of or return the device, unless this action would jeopardize the rights, safety, or welfare of a subject.
(b) Unanticipated adverse device effects. (1) A sponsor shall immediately conduct an evaluation of any unanticipated adverse device effect.
(2) A sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to subjects shall terminate all investigations or parts of investigations presenting that risk as soon as possible. Termination shall occur not later than 5 working days after the sponsor makes this determination and not later than 15 working days after the sponsor first received notice of the effect.
(c) Resumption of terminated studies. If the device is a significant risk device, a sponsor may not resume a terminated investigation without IRB and FDA approval. If the device is not a significant risk device, a sponsor may not resume a terminated investigation without IRB approval and, if the investigation was terminated under paragraph (b)(2) of this section, FDA approval.
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Sec. 812.47 Emergency research under 50.24 of this chapter.
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(a) The sponsor shall monitor the progress of all investigations involving an exception from informed consent under § 50.24 of this chapter. When the sponsor receives from the IRB information concerning the public disclosures under § 50.24(a)(7)(ii) and (iii) of this chapter, the sponsor shall promptly submit to the IDE file and to Docket Number FDA-1995-S-0036 in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, copies of the information that was disclosed, identified by the IDE number.
(b) The sponsor also shall monitor such investigations to determine when an IRB determines that it cannot approve the research because it does not meet the criteria in the exception in § 50.24(a) of this chapter or because of other relevant ethical concerns. The sponsor promptly shall provide this information in writing to FDA, investigators who are asked to participate in this or a substantially equivalent clinical investigation, and other IRB's that are asked to review this or a substantially equivalent investigation.
[61 FR 51531, Oct. 2, 1996, as amended at 64 FR 10943, Mar. 8, 1999; 88 FR 16880, Mar. 21, 2023]
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Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360bbb-8b, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b-263n.
Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.
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