Responsibilities

Responsibilities of Sponsors for Significant Risk Device Studies

General responsibilities (§812.40)

Sponsors are responsible for selecting qualified investigators and providing them with the information that they need to conduct the investigation properly. They must also ensure proper monitoring of the investigation and IRB review and approval, submit an IDE application to FDA for significant risk device studies, and inform the IRB and FDA promptly of any significant new information about the investigation.

FDA and IRB approval (§812.42)

A sponsor cannot begin an investigation or any part of an investigation until an IRB and FDA have both approved the application or supplemental application.

Selecting Investigators (§812.43)

A sponsor is responsible for selecting investigators qualified by training and experience to investigate the device.

Selecting Monitors (§812.43)

A sponsor must select monitors qualified by training and experience to monitor the investigational study in accordance with the IDE and other applicable FDA regulations.

Device Control (§812.43)

A sponsor can ship investigational devices only to qualified investigators participating in the investigation.

Investigator Agreements (§812.43)

A sponsor must obtain a signed agreement from each participating investigator that includes;

• the investigator's curriculum vitae,
• a statement of the investigator's relevant experience, including the dates, location, extent, and type of experience, where applicable,
• an explanation of the circumstances that led to termination of a study if the investigator was involved in an investigation or other research that was terminated,
• a statement of the investigator's commitment to:
  •  conduct the investigation in accordance with the agreement, the investigational plan, the IDE and other  applicable FDA regulations, and conditions of approval imposed by the reviewing IRB or FDA,
  •  supervise all testing of the device involving human subjects. and
  •  ensure that the requirements for obtaining informed consent are met.
• sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement as required under 21 CFR 54, Financial Disclosure by Clinical Investigators. The sponsor shall also 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 one year following completion of the study. (The financial certification or disclosure is submitted in the PMA or Premarket Notification 510(k) application. It should not be submitted in the IDE application.)

Informing investigators (§ 812.45)

A sponsor must supply all investigators participating in the investigation with copies of the investigational plan and a report of prior investigations of the device.

Monitoring (§ 812.46)

Securing Compliance

A sponsor who discovers that an investigator is not complying with the signed agreement, the investigational plan, the IDE requirements, any other applicable FDA regulations, or any conditions of approval imposed by the reviewing IRB or FDA must promptly either secure compliance, or discontinue shipments of the device to the investigator and terminate the investigator's participation in the investigation. A sponsor must also require that the investigator dispose of or return the device, unless this action would jeopardize the rights, safety, or welfare of a subject.

Unanticipated Adverse Device Effects

The sponsor must immediately conduct an evaluation of any unanticipated adverse device effect. A sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to subjects must terminate all investigations or parts of the investigations presenting that risk as soon as possible. Termination must occur no later than 5 working days after the sponsor makes this determination and no later than 15 working days after the sponsor first received notice of the effect.

Resumption of Terminated Studies

For significant risk device investigations, a sponsor may not resume a terminated investigation without IRB and FDA approval. For a nonsignificant risk device investigation, a sponsor may not resume a terminated investigation without IRB approval. If the nonsignificant risk study was terminated for unanticipated adverse device effects, the sponsor must also obtain FDA approval.

Sponsor records (§ 812.140)

The sponsor must maintain accurate and complete records relating to the investigation. These records include;

See Records for additional information on recordkeeping requirements.

Sponsor Reports (§812.150)

The sponsor must provide the following reports in a timely manner to FDA, the IRB's, and/or the investigators.

See Reports for more information regarding required reports.

Labeling (§812.5)

Under §812.5 an investigational device or its immediate package must bear a label with the following information:

• the name and place of business of the manufacturer, packer, or distributor;
• the quantity of contents, if appropriate; and
• the statement, "CAUTION ­­ Investigational device. Limited by Federal (or United States) law to investigational use."

The label must also describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.

The labeling of an investigational device must not contain any false or misleading statements nor imply that the device is safe or effective for the purposes being investigated.

The sponsor should provide detailed information on device labeling in the investigational protocol. This information may vary depending on the device and the nature of the study. Product labeling should be sufficient to ensure stability of the test article for the duration of the study (storage requirements, calibration procedures), bear sufficient directions for proper administration, and detail procedures to follow in the event of patient injury.

Promotion of Investigational Devices (§812.7)

Under §812.7, a sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator cannot:

• the name and place of business of the manufacturer, packer, or distributor;
• the quantity of contents, if appropriate; and
• the statement, "CAUTION ­­ Investigational device. Limited by Federal (or United States) law to investigational use."

The label must also describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.

The labeling of an investigational device must not contain any false or misleading statements nor imply that the device is safe or effective for the purposes being investigated.

The sponsor should provide detailed information on device labeling in the investigational protocol. This information may vary depending on the device and the nature of the study. Product labeling should be sufficient to ensure stability of the test article for the duration of the study (storage requirements, calibration procedures), bear sufficient directions for proper administration, and detail procedures to follow in the event of patient injury.

Responsibilities of Investigators for Significant Risk Device Studies

The investigator is responsible for protecting the rights, safety, and welfare of subjects. An investigator must conduct the investigation in accordance with the signed agreement with the sponsor, the investigational plan, the IDE regulation and other applicable FDA regulations, and any conditions of approval imposed by an IRB and FDA. (§812.100)

While waiting approval of an IDE application, an investigator may determine whether or not potential subjects would be interested in participating in an investigation, but cannot request written informed consent or allow any subjects to participate before obtaining IRB and FDA approval.  (§812.110)

An investigator is responsible for obtaining informed consent under 21 CFR Part 50.

Supervision of device use (§812.110)

An investigator can permit use of the investigational device only with subjects under his/her supervision and cannot not supply an investigational device to any person not authorized under the IDE regulation to receive it.

Financial Disclosure (§812.110)

The clinical investigator must disclose to the sponsor sufficient accurate financial information to allow the IDE applicant (or sponsor) to submit certification or disclosure of financial interests under 21 CFR 54. The investigator must update the information if any relevant changes occur during the course of the investigation and for one year following completion of the study.

Device Disposal (§812.110)

Upon completion or termination of a clinical investigation or the investigator's part of the investigation or at the sponsor's request, an investigator must return to the sponsor any remaining supply of the device or dispose of the device as the sponsor directs.

Records (812.140)

The investigator must maintain accurate and complete records relating to the investigation. These records include;

See Records for additional information on recordkeeping requirements.

Investigator Reports (812.150)

The investigator must provide the following reports in a timely manner to the sponsor and/or the IRB.

• Unanticipated Adverse Device Effects
• Withdrawal of IRB Approval
• Progress Reports
• Deviations from the Investigational Plan
• Informed Consent
• Final Report
• Other Reports 

See Reports for more information regarding required reports.

Last modified date July 21, 2003