early feasibility study

FDA Clarifies Early Feasibility Study (EFS) Program for Early-stage Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has provided qualification and submission details for its Early Feasibility Study (EFS) program.
  • The EFS program targets novel and innovative devices for which little or no prior clinical and non-clinical data exist.

New FDA IDE Guidance for Early Feasibility Studies

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.

New FDA Guidance on IDEs for Early Feasibility Studies

The US Food and Drug Administration is proposing a new policy for Investigational Device Exemption (IDE) applications for