- FDA issued a final guidance document on the benefits and risk factors that medical device makers should consider when submitting 510(k) premarket notifications for devices with technological characteristics that differ from a predicate device. The characteristics can be materials, design, energy source or other product features.
- The recommendations will help in determining substantial equivalence for devices with different characteristics that do not raise new questions of safety and effectiveness, FDA said.
- FDA plans to hold a webinar for manufacturers on Nov. 1 to explain the new guidance.
FDA is formalizing an approach for moderate-risk devices reviewed under the 510(k) program that is similar to the agency’s incorporation of benefit-risk principles into its review process for high-risk medical devices.
The new policy aims to make the approval process more efficient for devices with technological improvements by clarifying how benefit-risk principles are applied, FDA Commissioner Scott Gottlieb said in a statement. He said changes to the premarket approval process for high-risk devices have contributed to a four-fold increase in the number of new products approved annually.
The 510(k) submission process already requires a device maker to demonstrate substantial equivalence to a predicate device. FDA said the new guidance recognizes that medical devices reviewed under the process may have technological characteristics that differ from those of the predicate device.
The guidance addresses situations where the benefits and risk level of a new device may be either higher or lower than that of the predicate device. In these cases, FDA recommends conducting an updated benefit-risk assessment to determine if the new device meets the same standard established by the predicate device.
"This guidance does not add new requirements for submitters, it does not change the 510(k) premarket review standard, nor does it create extra or new burdens on 510(k) submissions," FDA said.
In the guidance document, FDA said benefit-risk issues could arise with new devices in a 510(k) submission under several scenarios, including: a change in device design or principle of operation, material differences that affect device performance, where there is a higher risk of malfunction, or where comparative testing yielded substantially different results.
Industry groups including AdvaMed, the Medical Imaging Technology Alliance (MITA) and the Medical Device Manufacturers Association (MDMA) have supported FDA’s plan to include the identification of benefit-risk factors in the 510(k) review process.
In comments submitted to the agency on the draft guidance, MITA said it supports FDA’s goal of speeding patient access to safe and effective devices and providing patients with more science-based information.
MDMA, in its comments on the draft, cautioned that the new plan gives FDA more flexibility that could leave room for significant variation in the interpretation and application of the recommendations.