Medical device trials: what sites need to know

How are device studies classified?

FDA's IDE regulations, 21 CFR part 812, describe significant risk (SR) and nonsignificant risk (NSR) device studies, plus exempt studies (FDA).

• Significant risk: the study may not begin until FDA approves the IDE and the IRB approves the study, and everyone follows the full IDE regulations (FDA).
• Nonsignificant risk: no IDE application to FDA; the study follows abbreviated requirements in 21 CFR 812.2(b), and the IRB serves as FDA's surrogate for review and continuing review (Advarra).

Who decides the risk level?

The sponsor makes an initial determination and presents it to the IRB. If FDA has not already decided, the IRB reviews whether it agrees; if FDA has made the determination, FDA's decision is final (Advarra).

How do device studies differ for a site?

• Investigator agreement under 21 CFR 812 rather than Form FDA 1572.
• Device accountability: receipt, use, and return logs for every unit. Inadequate product accountability is a recurring FDA inspection finding (FDA).
• Procedure heavy visits, often involving surgeons or proceduralists and hospital partners.
• Billing questions: Medicare coverage of routine costs follows NCD 310.1, and the investigational item itself is not a routine cost unless covered outside the trial (CMS).

Should your site take device studies?

They can diversify revenue for sites with the right specialists and procedure access. The patients are often managed by surgeons, cardiologists, orthopedists, and other proceduralists rather than primary care, so recruitment runs through specialist relationships. Sites that already know those physicians can enroll device studies that others cannot.

Related: adding a therapeutic area.