New guidance from the US Food and Drug Administration recommends information medical device manufacturers should include in applications for Investigational Device Exemption (IDE) approval of early feasibility studies. These recommendations are pertinent for manufacturers who must provide clinical data for 510(k) premarket notification and Premarket Approval (PMA) submissions.

The guidance urges IDE applicants to provide information that demonstrates proper benefit-risk analysis as well as subject protection processes to increase likelihood of approval for early feasibility studies of their devices.

Key elements of the FDA’s new policy for early feasibility study IDE approval include:

• Approval of early feasibility IDE applications may require less nonclinical data than for traditional feasibility or pivotal studies
• Applicants should identify data needed to support early feasibility studies according to comprehensive device evaluation strategies
• Allowance for timelier device and clinical protocol changes during early feasibility studies

In general, the FDA’s new approach to IDE reviews and approvals for early feasibility studies is intended to enable 510(k) and PMA applicants to begin clinical studies earlier in their US registration processes.

Stewart Eisenhart