Regulatory Open Forum

 View Only
  • 1.  changes under EFS IDE

    This message was posted by a user wishing to remain anonymous
    Posted 16 days ago
    This message was posted by a user wishing to remain anonymous

    Hello regulatory friends!!

    The early feasibility study (EFS) guidance states the following "Early feasibility studies involve the investigation of devices that may be in a rapid phase of device iteration. If clinical information is needed after device modification and further device iterations are expected, a sponsor may submit an IDE supplement, including a request for expansion of the early feasibility study."

    From your experience, what kind of device iterations are permitted under EFS supplement? Some examples would be highly appreciated.


  • 2.  RE: changes under EFS IDE

    Posted 16 days ago

    DA allows some flexibility for device changes under EFS supplements. The scope of permitted changes generally falls into these categories:

    • Minor Iterations: Small tweaks like software updates, minor dimension changes, or material changes without affecting biocompatibility.
    • Moderate Iterations: Changes impacting a component, delivery parameters, or the addition of non-invasive sensors.
    • Significant Iterations: These might require a new IDE application due to changes in the device's fundamental mechanism or intended use.

    Dinesh Puppala RAC
    Regulatory Affairs Lead
    Mountain View CA
    United States
    Linkedin -