FDA update – March 10, 2011

FDA’s new guidance on Class IIb devices

This summer medical devices classification system will add a new class to it that is class IIb. So CDRH is coming up with the new guidance to define, as a heuristic, a subset of class II devices called “class IIb” devices. Clinical information, manufacturing information, or, potentially, additional evaluation in the post market setting, would typically be necessary to support a substantial equivalence determination of class IIb medical devices. Potential candidates for this device subset may include implantable devices, life-sustaining devices, and life-supporting devices, which present greater risks than other class II device types.

Delineating between “class IIa” and “class IIb” would not reconfigure the current, three-tiered device classification system established by statute; it would representonly an administrative distinction.

Reasons behind developing “class IIb” guidance are listed below:

  • To provide greater clarity regarding what submitters would generally be expected to provide in their 510(k)s for certain types of class IIb devices.
  • To answer questions appropriate for a substantial equivalence determination and de novo classification process for class IIb devices.
  • To guide when to remove a specific type of device from “class IIb” subset as its technology and its risk/benefit profile in clinical practice become better understood.
  • To advise manufacturers of “class IIb” devices to engage with the Center to discuss the type of evidence appropriate for their devices.
  • To provide greater clarity regarding the circumstances in which it will request clinical data in support of a 510(k), and what type and level of clinical data are adequate to support clearance.
  • To define the term “clinical data” to foster a common understanding among review staff and submitters about types of information that may constitute “clinical data.”
  • Circumstances under which postmarket surveillance studies might be appropriate, and include a discussion of such studies.
  • To provide greater clarity regarding what situations may warrant the submission of manufacturing process information as part of a 510(k), and include a discussion of such information
  • To clarify when it is appropriate to use its authority to withhold clearance on the basis of a failure to comply with good manufacturing requirements in situations where there is a substantial likelihood that such failure will potentially present a serious risk to human health, and pre-clearance inspections.

If there are any questions on this new FDA guidance please contact us via email at info@mdiconsultants.com and Ref:Class IIb guidance.