New FDA Draft Guidance on Bringing New, Innovative Devices to Market Using 510(k) Process

Regulatory NewsRegulatory News
| 14 July 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) today issued a new draft guidance on the 510(k) process outlining the factors companies should consider when trying to bring a new device to market.


The 510(k), or premarket notification, process differs from the premarket approval process in that regulators are partially assessing the safety and efficacy of the device based on its substantial equivalence (SE) to an already-marketed product, known as a predicate device. This allows the company to rely more on the predicate device's record of safety, and less on new clinical evidence.

Accordingly, much of the focus in 510(k) process is on the ways in which the new device isn't substantially equivalent to predicate devices. As seen in some recent case studies, such as the case of metal-on-metal hip implants, the failure to fully appreciate the differences of new device iterations cleared through the 510(k) process can have disastrous effects on patients.

New Guidance

FDA's newest 510(k) draft guidance—which comes after a much-maligned 510(k) program guidance was withdrawn—is meant to focus on those differences, which FDA refers to as "different technological characteristics."

The aims of the guidance, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, are two-fold: to help industry demonstrate SE in its applications, and to help FDA reviewers determine which devices are SE.

The guidance notes some of the basic elements of the SE process. For example, a device is only considered SE if the intended use is the same as the predicate. In addition, the two devices must be found to have "the same technological characteristics," or alternately that the technological differences do not alter the safety or efficacy profile of the device.

"If FDA determines that there are differences in the technological characteristics between the new device and the predicate device, and that the different technological characteristics raise different questions of safety and effectiveness, FDA will find the new device to be not substantially equivalent (NSE) to the predicate device," FDA explains.

Conversely, if FDA doesn't think those differences raise any problems, the device can be found to be SE assuming all other conditions are met.

So how are sponsors to obtain SE determinations when devices have technological differences? They use performance data, FDA explained.

Sponsors are advised to generate performance data on the use of the device. In turn, FDA will then evaluate that data to determine if it constitutes "valid scientific evidence" about the safety and efficacy of the device.

Assessment Points

FDA's guidance document goes on to discuss the various types of assessments it will conduct with the data.

For example, what types of benefits will the device have for patients? How substantial will those benefits be, how likely are they to occur, and how long will they last? These benefits are assessed both individually and "in the aggregate," FDA writes.

Safety risks are also assessed by regulators, such as device-related serious adverse events (SAEs), procedure-related complications, the probability of a harmful event occurring, the duration of harmful events and the risks of improper diagnosis (if a device is a diagnostic).

FDA also notes that it intends to take into account the particular disease or condition and, unusually, patient tolerance for risk and their perspective on the benefits of the device.

"Risk tolerance varies among patients, and affects individual patient’s decisions as to whether higher risks in the new device’s technology as compared to the predicate device are acceptable in exchange for a higher probable benefit," FDA wrote. "When evaluating benefits and risks, FDA recognizes that a patient-centric assessment of risk may identify patients who are reasonably willing to accept a higher level of risk to achieve a higher probable benefit or an additional type of benefit."

To date, FDA has mostly reserved discussion of patient-centric risk tolerance to pharmaceutical products, with little formal focus on medical devices.

Other considerations will include benefits to healthcare professionals and caregivers, risk mitigation strategies, the collection of postmarket data and the use of innovative technologies that improve public health.

Seven examples of 510(k) submissions are included within the draft guidance.

The guidance document is subject to a 90-day comment period.


Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics


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