On September 24, 2018, FDA released the final version of the “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510 (k)) with Different Technological Characteristics” Guidance, where the FDA communicates to the industry and its own staff the factors to take into consideration for the assessment of the risk-benefit profile of a new device (proposed device) in comparison to a predicate device in a 510 (k).
The aforementioned Document is consistent with the FDA’s “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. Guidance for Industry and Food and Drug Administration Staff” , emessa il 28 luglio 2014 che identifica, spiega e chiarisce ciascuno dei punti critici nel processo decisionale utilizzato da FDA per determinare la sostanziale equivalenza (SE). Guidance for Industry and Food and Drug Administration Staff” guideline, issued on July 28, 2014, which identifies, explains and clarifies each of the critical points in the decision-making process used by the FDA to determine the substantial equivalence (SE).
Please note that the applicants of a new 510 (k) must provide evidence to the FDA that the proposed device is substantially equivalent (SE) to a predicate device (already marketed in the United States), using the criteria identified in section 513 (s) of the FD&C Act (21 U.S.C. 360c(i)(3)). Once the FDA determines that the device and its predicate have the same intended use, the next step of the SE demonstration is proving that the proposed device is just as safe and effective as the predicate device.
The new guideline applies once the FDA has established that the proposed device and its predicate have the same intended use and different technological characteristics that do not raise additional risks related to safety and effectiveness. Therefore, it is particularly useful in situations where, when comparing the proposed device with its predicate, there is:
- Increased risk, increased benefit;
- Increased risk, equivalent benefit;
- Decreased benefit, decreased risk;
- Decreased benefit, equivalent risk.
This guideline, simply by explaining and clarifying the FDA’s decision-making process, does not add new regulatory requirements for applicants, nor does it change the review standards for 510(k) requests or create additional burdens on what is routinely presented in a 510(k).