The first guidance “Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review” explains the agency's approval process for diagnostic and therapeutic devices, specifically:
- How the agency weighs the benefits and risks of a device
- How the agency assess the seriousness of a disease or condition
- How many people would use the device if approved
- The availability of other devices approved to treat the same condition
In the second draft document “Design Considerations for Pivotal Clinical Investigations for Medical Devices”, the FDA laid out its expectations for clinical trials for medical devices. The agency stated that it looks for a study to provide reasonable assurance that the device is safe and effective.
Back in July 2011, FDA issued a guidance on “in Vitro Companion Diagnostic Devices” where the In Vitro Companion diagnostic device (IVD companion diagnostic device) is defined as an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. The guidance intended to accomplish the following:
- Define in vitro 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
- Describe certain statutory and regulatory approval requirements relevant to therapeutic product labeling that stipulates concomitant use of an IVD companion diagnostic device to ensure safety and effectiveness of the therapeutic product
No matter what the device is, if clinical trials are required, the statistical analyses can be based on the FDA guidance “Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests” that was issued in 2007.
In Device field, not all approval requires clincial trials. If clinical trials are required, they do not have to be interventional. If clinical trials are interventional, they do not have to be randomized, controlled. If clinical trials are randomized, controled, they do not have to be double-blinded. Some clinical trials in device field may be using the samples (for example blood samples) from patients with no intervention performed. The blood samples could be historical retains or prospectively collected. The use of the blood samples for device clinical trial still needs the informed consent from the patient.