TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 812 - INVESTIGATIONAL DEVICE EXEMPTIONS

subpart c - RESPONSIBILITIES OF SPONSORS

812.43 - Selecting investigators and monitors.

  (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]