FDA requires an IDE prior to a sponsor initiating a clinical investigation for devices which FDA has determined to be Significant Risk. Through the IDE, the sponsor must demonstrate how the risks to the subjects are not outweighed by the anticipated benefits. If FDA is unable to determine that the benefits to the patients are greater than the potential risks, the IDE will not be granted. This guidance document brings into discussion several key factors FDA considers when making this assessment.
FDA breaks down assessment of risks to study subjects into five areas.
- Type(s) and severity of risk(s).
This includes basic safety, device-related adverse events, device related non-serious adverse events, procedure-related complications due to the investigations, risks associated with the study itself, and risks from false-positive or false-negative results for diagnostics.
- Likelihood or probability of risk(s).
FDA would like to see the number of harmful events per patient or the number of harmful events per unit of time, the proportion of the intended population that would be expected to experience a harmful event, as well as the likelihood of a given subject or study group experiencing a harmful event.
- Duration of risk(s).
How long the adverse even lasts is considered by FDA.
- Risk Management.
Risk control measures are intended to reduce the risk to an acceptable level. Sponsors should conduct an initial determination regarding which risk controls are appropriate for their proposed IDE study.
- Residual risk evaluation.
FDA considers what risks are present after risk control measured has been applied.
FDA will also consider
- Informed Consent;
- Device Development Pathway;
- Direct benefits to Subjects;
- Benefits to Others; and
- Other Risks
when reviewing and IDE.
Based on these criteria, FDA will either grant approval of the IDE, approval with conditions, or disapproval.
I Please use the follow link to access the Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs)
? Email us at firstname.lastname@example.org if you have further questions. Ref: IDE Benefit-Risk Determination