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Overview of the IDE Process

Investigations with devices covered by 21 CFR 812 are subject to regulatory controls specific to the determined level of risk.

The IDE regulation distinguishes between significant and nonsignificant risk device studies. The procedures for obtaining approval of the study are specific to the determined level of risk. Guidance on distinguishing between significant and nonsignificant risk are outlined in the FDA document "Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies."

Also, some types of studies are exempt from the IDE regulations.

Significant risk device

A significant risk device presents a potential for serious risk to the health, safety, or welfare of a subject. Significant risk devices include:

  • Implants
  • Devices that support or sustain life
  • Devices that are significantly important in diagnosing, curing, mitigating, or treating disease or in preventing impairment to human health.

Examples:

  • Sutures
  • Cardiac pacemakers
  • Hydrocephalus shunts
  • Orthopedic implants

Studies of devices that pose a significant risk require both FDA and an Institutional Review Board approval prior to initiation of the clinical study. In order to conduct a study involving a significant risk device, a sponsor must:

  • Submit a complete IDE application to FDA for review and obtain approval;
  • Submit the investigational plan and report of prior investigations to the IRB at each institution where the investigation is be conducted for review and approval; and
  • Select qualified investigators, provide them with all necessary information on the investigational plan and report of prior investigations, and obtain signed Investigator Agreements from them.

After the FDA receives an IDE application, it notifies sponsors in writing of the date the FDA received the original application and the IDE number assigned (receipt of supplements and amendments are not acknowledged). Once the FDA has acknowledged receipt of the IDE application, the sponsor must wait 30 calendar days before initiating any clinical trial. During this period, the FDA may inform the sponsor that the IDE is approved, approved with conditions, or disapproved. In cases of disapproval, the sponsor may respond to the cited deficiencies and/or request a regulatory hearing.

Download instructions on the IDE Application Process (PDF)

Nonsignificant risk Device

Nonsignificant risk devices are devices that do not pose a significant risk to human subjects. Examples include:

  • Contact lenses and lens solutions
  • Ultrasonic dental scalers
  • Foley catheters

A nonsignificant risk device study requires only IRB approval prior to initiation of the clinical study. Sponsors of studies involving nonsignificant risk devices are not required to submit an IDE application to the FDA for approval. Sponsors must, however, present an explanation to the IRB as to why the device does not pose a significant risk. If the IRB disagrees and determines that the device poses a significant risk, the sponsor must report this finding to the FDA within five working days.

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