FDA update 13th July 2011

Draft Guidance for Industry and Food and Drug Administration Staff In Vitro Companion Diagnostic Devices

This guidance is intended to assist

  • sponsors who are planning to develop a therapeutic products  that depends on the use of an in vitro companion diagnostic device (or test) for its safe and effective use
  • sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product.
  • Define in vitro companion diagnostic device (hereafter referred to as an “IVD companion diagnostic device”)
  • Explain the need for FDA oversight of IVD companion diagnostic devices
  • Clarify that, in most circumstances, if use of an IVD companion diagnostic device is essential for the safe and effective use of a therapeutic product, the IVD companion diagnostic device and therapeutic product should be approved or cleared contemporaneously by FDA for the use indicated in the therapeutic product labeling
  • Provide guidance for industry and FDA staff on possible premarket regulatory pathways and FDA’s regulatory enforcement policy. As used in this guidance, therapeutic product includes therapeutic, preventive, and prophylactic drugs and biological products.

Although this guidance does not expressly address therapeutic devices intended for use with in vitro diagnostics, the principles discussed in this guidance may also be relevant to premarket review of such devices.

DA will apply a risk-based approach to determine the regulatory pathway for IVD companion diagnostic devices, as it does with all medical devices. This means that the regulatory pathway will depend on the level of risk to patients, based on the intended use of the IVD companion diagnostic device and the controls necessary to provide a reasonable assurance of safety and effectiveness. Thus, the level of risk together with available controls to mitigate risk will establish whether an IVD companion diagnostic device requires a premarket application (PMA) or, a 510(k),10 FDA advises sponsors to consult early with FDA on the likely regulatory pathway for the IVD companion diagnostic device.

Conclusion:FDA encourages sponsors considering developing either the therapeutic or IVD companion diagnostic devices discussed in this guidance to request a meeting with both relevant device and therapeutic product review divisions to ensure that product development plans will produce sufficient data to establish the safety and effectiveness of the IVD companion diagnostic device/therapeutic product pair.

For more information on this guidance you can go to the following linkhttp://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM262327.pdf or contact mdi atinfo@mdiconsultants.com REF: New Draft Guidance  In Vitro Companion Diagnostic Devices .