Codeveloped with Oncology Drugs
The FDA released a procedural guidance in October 2019 which provides a streamlined process for submitting investigational in vitro devices (IVD) being codeveloped with investigational drugs in the same clinical protocol. The process requires one of the sponsors to take the lead role on the device with the agency and submit specific information, such as
- A description of the device,
- How the results for the investigational IVD will be applied in the clinical trial,
- A description of the patient population and what is known about the biomarker in that population,
- The specimen type used for the investigational IVD, and
- Whether a biopsy for the investigational IVD could pose a serious risk to the subject’s health, safety, or welfare.
Within 30 days of this submission, CDER or CBER will consult with their device review colleagues in CDRH or CBER to determine whether the use of the device in the trial is Significant Risk (SR), Non Significant Risk (NSR), or Exempt. Only those investigational devices with an SR classification would require an approved IDE to use the device in the trial.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2019 Katrina Rogers