Significant risk device (SR device)

Significant risk device is an investigational device that:

1. is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
2. is for use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject;
3. is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
4. otherwise presents a potential for serious risk to a subject.

Examples include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants.

Studies of devices that pose a significant risk require both FDA and an Institutional Review Board (IRB) approval prior to initiation of a clinical study. FDA approval is obtained by submitting an IDE application to FDA (§812.20).

In order to conduct a significant risk device study, a sponsor must:

• submit a complete IDE application (§812.20) to FDA for review and obtain FDA approval of the IDE;
• submit the investigational plan and report of prior investigations (§812.25 and §812.27) to the IRB at each institution where the investigation is to 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.