FDA Proposes Guidelines to Clarify Benefit-Risk Determinations for Medical Devices
The FDA’s new draft guidelines focus on premarket approval applications (PMAs), the regulatory pathway for high-risk medical devices. The recommendations made in the guidance are, according to the agency, intended to improve the predictability, consistency and transparency of the premarket review process for applicable devices, and should help manufacturers go through the approval process easier.
Device reviewers also may consider whether the device is new or a first-of-a-kind technology as part of the benefit-risk determination, particularly if the device treats a disease that has no other treatment.
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Summary of recommendations
Applicability
The guidance applies to:
- Devices subject to premarket approval (PMA) applications
- In limited cases, devices subject to premarket notification (510(k)) requirements
- Both diagnostic devices and therapeutic devices
Safety and effectiveness data
When reviewing PMAs, the FDA uses safety data and effectiveness data:
- The safety data addresses risk, and the manufacturer’s ability to mitigate that risk.
- The effectiveness data considers benefits, as well as other information, to determine whether the probable benefits outweigh the probable risks associated with use of the device.
Safety and effectiveness data alone may not provide a complete picture of the benefits and risks. FDA medical device reviewers objectively look at other factors such as the severity of the disease the product diagnoses or treats and whether or not alternative tests or treatments are available.
Both clinical and non-clinical data can play a role in the FDA’s benefit-risk determinations.
Factors FDA considers in making benefit-risk determinations
Measures for effectiveness of devices:
| The type of benefits |
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| The magnitude of the benefits in the individual patient |
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| The probability of the patient experiencing a benefit |
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| The duration of effects |
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Measures for safety of devices
The extent of the probable risk/harm is measured by taking into account the following factors:
| Number, severity, and types of harmful events associated with the use of the device |
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| Probability of a harmful event | The percent of the intended population that would expect to experience a harmful event. |
| Duration of harmful events | Some devices can cause temporary, minor harm; some devices can cause repeated but reversible harm; and other devices can cause permanent, debilitating injury. |
| Risk from false-positive or false-negative for diagnostics |
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The agency also considers the number of different types of harmful events that can potentially result from using the device and the severity of their aggregated effect. When multiple harmful events occur at once, they have a greater aggregated effect.
Additional factors for risk/benefit determination
| Uncertainty |
The degree of certainty of the benefits and risks of a device is a factor the FDA considers when making benefit-risk determinations. |
| Characterization of the disease |
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| Patient tolerance for risk | Different factors can influence patient risk tolerance, including:
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| Risk mitigation | The use of mitigations such as warning labels can minimize the likelihood of a harmful event occurring. |
| Novelty of technology | Devices representing or incorporating new technologies, especially those that are first-of-a-kind, may provide a less than optimal benefit, but may also offer advantages that did not previously exist. |
Benefit/risk worksheet
The guidance proposes that medical device reviewers use a worksheet to document how they make benefit-risk determinations. In certain cases, this document could be made public post-approval, making the FDA’s decision making process even more transparent.
Additional resources
- Read the draft FDA guidance for benefit risk determination of medical devices in full
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