On August 15, 2011, FDA issued its Draft Guidance for Industry and Food and Drug Administration Staff – Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review. This Guidance is applicable to both diagnostic and therapeutic devices subject to premarket approval (PMA) applications and in some cases to devices subject to the premarket notification (510(k)) process. This draft Guidance follows FDA’s August 4, 2010 510(k) Working Group Preliminary Report and Recommendations that focused on three key objectives: fostering device innovation, creating a more predictable regulatory environment, and enhancing device safety. It is intended “to provide greater clarity for FDA reviewers and industry regarding the factors FDA considers when making benefit-risk determinations during the premarket review process for” covered devices, and, by the uniform application of the factors it describes, to “improve the predictability, consistency, and transparency of the premarket review process” – something long awaited and desired by the industry.  


The draft Guidance outlines the many factors considered by FDA in fulfilling its mission to assess the benefits of a device versus its probable risks. In measuring the effectiveness of a device, FDA considers the type of benefit provided by the device, the extent of the probable benefit, the probability of a patient actually experiencing the benefit, and the duration of the effects of the benefit. In assessing the safety of a device, FDA considers the extent of the probable risk of harm; the number, severity, and types of harmful events associated with use of the device (including serious adverse events, non-serious adverse events and indirect harms); the probability and duration of a harmful event; and, in the case of diagnostics, the risks from false-positives or false-negatives. Additional factors considered by FDA in weighing the benefits and risks of a device include the novelty of the device technology, the degree of uncertainty as to whether the device will confer the intended benefits, the character of the disease or condition that will be treated/diagnosed by the device, the patient tolerance for risk (viewed against the disease severity and chronicity), the availability of alternative treatments or diagnostics, and whether the risks of the device are capable of mitigation.

To illustrate how these factors apply in the medical device review process, the draft Guidance includes both hypothetical and actual scenarios of device approval submissions and the FDA’s hypothetical and actual benefit-risk determinations in approving or declining approval of these devices. FDA’s draft Guidance also includes a Worksheet for Benefit-Risk Determinations proposed to be used by medical device premarket reviewers across the different FDA divisions in making device benefit-risk determinations. The FDA believes that use of the worksheet will “be very helpful to maintaining the consistency of review across different review divisions and better assuring that an appropriate decision is reached,” and will provide sponsors better understanding of FDA’s decisions and the factors it considers, “by documenting reviewers’ thought processes as part of the review file and, in certain cases, the publicly available summary of [FDA’s] decision.”  

The FDA is taking public comments on this draft Guidance through November 15, 2011. By participating in the regulatory process, medical device companies can help shape the agenda of priorities and the regulatory framework pertaining to issues of critical importance to their operations. Medical device companies therefore should consider informing FDA of their experiences, concerns, and suggestions regarding the draft Guidance. Thompson Hine’s lawyers are available to advise and assist those in the medical device community who may be affected by this draft Guidance or the changing regulatory environment.  

The draft Guidance can be viewed and downloaded on the FDA website.