Aug 15, 2011

The US Food and Drug Administration has published draft guidance on the factors agency reviewers use to make benefit-risk decisions for premarket approval (PMA) medical device applications.

In making these factors public, the regulator hopes to improve predictability, consistency and transparency of its PMA process (as well as some 510(k) reviews).

First, the FDA considers measures for effectiveness of devices. Under this category, reviewers measure the type, magnitude and probability of benefits provided by a device, as well as the duration of those benefits for the patient.

Second, the agency considers measures for safety of devices. These include device-related serious and non-serious adverse events, procedure-related or indirect harms stemming from the device under consideration, and probability and duration of harmful events. Risks from false-positive or false-negative results produced by diagnostic devices also fall under this category of factors.

Additional factors the FDA lists in the guidance include uncertainty in terms of reviewers’ ability to determine reasonable assurances of safety and effectiveness; characterization of the disease or condition a device is designed to diagnose or treat; patient tolerance for risk, which can be affected by issues such as disease severity and chronicity; availability of alternative treatments; use of risk mitigations such as warning labelsto minimize the likelihood of harmful events; and novelty of technology used in a particular device.

The guidance also includes examples of how FDA reviewers use multiple combinations of factors to evaluate benefits and risks of particular medical devices. The FDA has also provided a draft of a Worksheet for Benefit-Risk Determinations in order to maintain more consistency in the PMA process, especially for devices requiring reviews across different agency divisions. 


  • Stewart Eisenhart