FDA determines whether PMA (pre-market approval) applications or De Novo classification requests provide a “reasonable assurance of safety and effectiveness” by “weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.” The FDA uses this determination to decide upon marketing approvals.
PMA applies to Class III medical devices, defined as those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
De Novo Classification Requests are a risk-based classification process that provides a marketing pathway for novel medical devices in which general controls alone, or general and special controls provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally market predicate device (i.e., no already approved device upon which to claim substantial equivalence)
Medical device manufacturers will submit valid scientific evidence that is used to support the claim that “the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or the device.”
Scientific evidence includes clinical and non-clinical testing. One of the most common and relied upon types of non-clinical testing methods is human factors and usability engineering testing under simulated conditions of use.
With the results of this scientific evidence, the FDA conducts a Benefit-Risk Determination, identifying probable risks and probable benefits as part of their equation.
What Factors does the FDA consider when making a Benefit-Risk Determination?
The FDA considers the following factors when determining a medical device’s benefit and risk profile:
Benefits of Device:
Type of Benefit:
The device’s impact on clinical management, patient health, and patient satisfaction (where end-user research conducted with an initial prototype can help)
Magnitude of Benefit:
Improvement or worsening of the endpoint
Probability of Patient Experiencing Benefit(s):
Who experiences the benefit (i.e., patients with which characteristics), how frequently, and how large is this patient group
Duration of Benefit Effects:
How long the benefits last
Risks of Device:
Severity, Types, Number, and Rates of Harmful Events associated with Device Use:
Device-Related Serious Adverse Events: e.g., life-threatening, serious injury or illness
Device-Related Non-Serious Adverse Events: harms attributed to the device that are less severe than serious harms
Procedure-Related Complications: harms not directly related to the device (e.g. harms related to the preparation)
Probability of a Harmful Event:
The proportion of the intended population that would likely experience harm
Duration of Harmful Events:
How long the harm lasts
Risk from False-Positive or False-Negative Results from Diagnosis:
Consequences and risks associated with unneeded treatment or missed treatment due to faulty diagnosis
Risk Mitigation techniques can help minimize the probability of harm and improve your benefit-risk profile and likelihood of approval. Most common risk mitigations involve clear labeling and restricting intended use. Sometimes training serves to mitigate risk as well.
If you’re in the process of developing a medical device and want to 1) get end-user feedback on a prototype to help improve your benefit-risk profile early in the design process and/or 2) conduct a use-related risk analysis (URRA) and validate your devices safety for 510(k) or De Novo submission, contact TIMBS Consulting.