IDE Sponsor Responsibilities – Nonsignificant Risk Device Studies

Responsibilities of Sponsors of Nonsignificant Risk Device Studies

The sponsor must:

• Label the device 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 sponsor should provide detailed information on device labeling in the investigational protocol.
• Obtain IRB approval of the investigation as a nonsignificant risk device study after presenting the reviewing IRB with a brief explanation of why the device is not a significant risk device and maintain such approval.
• Ensure that each investigator participating in an investigation of the device obtains informed consent under 21 CFR 50 for each subject under the investigator’s care and documents the consent, unless documentation is waived by an IRB under §56.109(c).
• Monitoring investigations.
  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.


• Maintain certain records and submit required reports. The following records must be maintained in one location and available for FDA inspection:
• the name and intended use of the device;
• the objectives of the investigation;
• a brief explanation of why the device is not a significant risk device;
• the name and address of each investigator;
• the name and address of each IRB;
• a statement of the extent to which the good manufacturing practices (21 CFR 820) will be followed in manufacturing the device.
• any other information required by FDA

The sponsor must maintain records concerning complaints and adverse device effects whether anticipated or not.

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

• Unanticipated Adverse Device Effects
• Withdrawal of IRB Approval
• Withdrawal of FDA Approval
• Progress Reports
• Recalls and Device Disposition
• Final Report
• Informed consent
• Significant Risk Device Determination
• Other Reports


• Ensure that participating investigators maintain the records of each subject’s case history and exposure to the device and ensure that participating investigators make the following required reports:


• Unanticipated Adverse Device Effects
• Withdrawal of IRB Approval
• Informed consent
• Other reports requested by a reviewing IRB or FDA


• Comply with the prohibitions in §812.7 against promotion and other practices.