FDA Releases Draft Guidance To Help Determine Substantial Equivalence for a Device that Has Different Technological Characteristics Than the Predicate Device

by Saul Ewing Arnstein & Lehr LLP


In a new Draft Guidance entitled, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, (the “Draft Guidance”) released on July 15, 2014, the Food and Drug Administration (“FDA”) explains how the agency determines whether a device is substantially equivalent (“SE”) to a predicate device in the 510(k) premarket notification process “when there are different technological characteristics between the new device and the predicate device that do not raise different questions of safety and effectiveness.” The agency is accepting comments and suggestions regarding the Draft Guidance until October 14, 2014. The Draft Guidance can be reviewed here.

Through the 510(k) process, a new device may be commercialized as SE to a predicate device if the new device has “the same intended use as the predicate device,” and

  1. “the same technological characteristics as the predicate device,” or
  2. “different technological characteristics,” but “information, including appropriate clinical or scientific data” “demonstrates that the device is as safe and effective as a legally marketed device and… does not raise different questions of safety and effectiveness that the predicate device.”

The Draft Guidance focuses on the second enumerated pathway above and, in particular, the FDA’s safety and effectiveness analysis. As described in the Draft Guidance, the FDA considers non-clinical and clinical performance data to evaluate the benefits and risks of the new device in comparison to the predicate device to assess whether the new device raises different questions of safety and effectiveness. While the FDA will consider only “valid scientific evidence” to evaluate benefits and risks, it may consider data that does not rise to the level of “valid scientific evidence” such as “isolated reports, random experience, reports lacking sufficient details to permit scientific evaluation, and unsubstantial opinions” to identify a device that has “questionable safety and effectiveness.”

The principal benefit-risk factors that the FDA considers when evaluating the safety and effectiveness of a new device as compared to the predicate device are as follows:




Probable Benefit/Risk

Impact of the new device on clinical management, patient health, patient satisfaction, survival, patient
function (improvement and loss
prevention), and symptom relief.

Device related serious and non-serious adverse events and procedure-related complications.

Probability of Experiencing Benefit/Risk

Predicted benefit, the size of the benefit (large or small), and the proportion of subjects who are expected to experience the benefit.

Predicted harmful event,
reoccurrence of the event, and the proportion of subjects who are expected to experience the event.

Duration of Benefit/Harmful Event

How long the benefit is expected
to last and whether repeated
treatments are necessary.

Duration and severity of the harmful event and aggregate of harmful events.

Potential Flawed Results

Magnitude of the benefit or change in study subjects’ condition or clinical management.

Likelihood of false positive and
false negative diagnosis from devices.

The FDA weighs and balances the benefits and risks related to the new device. For instance, in reviewing the benefits and risks of a new device as compared to the predicate, FDA will identify: the improvements that the new device brings; the risks associated with the improvements; and, determine whether the risks can be mitigated. If the risks can be mitigated, it is anticipated that the FDA will conclude the new device SE to the predicate device because while there are new risks associated with the new device, the new device is improved, the new risks can be minimized, and the benefits outweigh the risks. The FDA’s SE assessment is fact-intensive and evaluated on a case-by-case basis. The FDA will also evaluate the degree of certainty of achieving the benefit or risk, the characterization of the disease or condition for which the new device is meant to diagnose or treat (i.e., the natural history and progression of the disease), the patient’s risk tolerance and the margin of benefit, the benefit to the healthcare professional or caregiver (early interaction with the FDA is recommended for this benefit type), use of risk mitigation to improve the benefit profile, postmarket data (such as recalls and registry data), and innovative technology (which may warrant more tolerance for risk in order to introduce innovation).

The Draft Guidance, when finalized, will represent FDA’s “current thinking on benefit-risk factors” for new and predicate devices. The Draft Guidance does not bind the FDA. Entrepreneurs seeking to improve technological advances for products in the medical device industry – companies, physicians, academic medical centers – while maintaining safety and effectiveness would be well served to provide comments with respect to the Draft Guidance and review the final iteration of the Draft Guidance when it is published.

Written by:

Saul Ewing Arnstein & Lehr LLP

Saul Ewing Arnstein & Lehr LLP on:

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