Under §812.7, a sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator cannot: [11] • Commercialize an investigational device by charging the subjects or inves­tigators a higher price than that necessary to recover costs of manufacture, research, development, and handling. • Unduly prolong an investigation. If data developed by […]

If FDA disapproves an IDE application or proposes to withdraw an approval, FDA will notify the sponsor in writing. A disapproval order will contain a complete statement of the reasons for disapproval and will advise the sponsor of the right to request a regulatory hear­ing under 21 CFR §16. The FDA will provide an opportunity […]

The FDA will notify the sponsor (in writing) of the date it receives an IDE application. The FDA may approve, approve with modification, or disapprove an IDE application. FDA may request additional information about an investigation. The sponsor may provide the requested information or the sponsor may treat such a request as a disapproval of […]

Study approval must be obtained PRIOR to enrolling users at the study site. Each site must have an approval from the reviewing IRB for that site prior to the beginning the study. For significant risk-device studies, in addition to IRB approvals, the sponsor must also have an approved IDE from FDA prior to beginning the […]

The sponsor of the clinical trial is responsible103 for submitting the IDE application to FDA and obtaining Institutional Review Board (IRB) approval before the study can begin. Foreign companies wanting to conduct a clinical study in the United States MUST have a US sponsor.104 Under certain circumstances, the clinical investigator may wish to submit an […]

All clinical investigations of devices must have an approved IDE or be exempt from the IDE regulation. Investigations that are exempted from 21 CFR §812 are described in §812.2(c) of the IDE regulation. Studies exempt from the IDE regulation include: 1. a legally marketed device when used in accordance with its labeling; 2. a diagnostic […]

Nonsignificant risk devices are devices that do not pose a significant risk to the human subjects. Examples include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and foley catheters. A nonsignificant risk device study requires only an IRB approval prior to the initiation of a clinical study. Sponsors of studies involving nonsignifi­cant risk […]

A significant risk device presents a potential for serious risk to the health, safety, or welfare of a subject. Significant risk devices may include implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, miti­gating, or treating disease or in preventing impairment to human health, or have the […]

Investigations covered under the IDE regulation are subject to differing levels of regula­tory control, depending on the level of risk. The IDE regulation distinguishes between significant and nonsignificant risk device studies, and the procedures for obtaining approval to begin the study differ accordingly.87 Some types of studies are also exempt from the IDE regulations.