The second article addresses the matters related to the 510(k) decision-making process, including the review standard and predicate devices – similar devices already placed on the market and referred to demonstrate substantial equivalence.




The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the use of substantial equivalence in premarket notifications under the 510(k) framework. The guidance is intended to provide additional recommendations regarding the content of the submission, and also about the decision-making process. The scope of the document covers, inter alia, the following aspects:

  • The appropriate use of multiple predicates;
  • The processes associated with determining whether a new device with new indications for use has a new intended use;
  • The process for determining whether different technological characteristics raise different questions of safety and effectiveness;
  • When performance data, with special emphasis on clinical performance data, may be necessary to support an SE [substantial equivalence] determination;
  • How to develop 510(k) Summaries to promote greater transparency in the 510(k) decision-making process.

The recommendations provided in the guidance could be applied concerning any medical devices that are eligible for placing on the market under the 510(k) premarket notification framework irrespective of the particular center responsible for the application review. 

The authority additionally explains the specific nature of this guidance – it is stated that the document should not be construed as a replacement to existing device-specific guidance documents published earlier by the FDA, so they should be used in parallel. Should an applicant entity have any questions regarding the particular way the guidance documents should be applied, it is advised to contact the Agency for further clarifications. It is also important to mention that the regulatory matters related to the combination products are falling outside the scope of the present guidance. 

The 510(k) Decision-Making Process: Key Points 

Currently, 510(k) is the primary framework used to apply for marketing approval for medical devices in the US. Under this framework, an applicant should provide sufficient evidence demonstrating that the new medical device subject to review is “substantially equivalent” to a similar medical device already placed on the market (also referred to as a “predicate”). An applicant should provide a detailed comparison of two devices and justify the differences if any (it should be demonstrated that differences would not adversely impact the safety and performance of a medical device).

In most cases, a Traditional 510(k) pathway is used. The scope of information to be submitted by the applicant is prescribed by regulation 21 CFR 807.87, while additional recommendations are provided in a respective guidance document issued by the FDA. The general requirements regarding the information to be provided are the same for all 510(k) submissions, however, certain changes could have a place due to the nature of the device subject to review and specific aspects associated thereto. These aspects are addressed in numerous device-specific guidance documents issued by the Agency. Should an applicant have any concerns regarding the scope of information to be included in the submission, it may contact the authority in advance and request advice under the pre-submission framework. At the same time, voluntary consensus standards recognized by the FDA could be used for all submissions. Medical device manufacturers are allowed to refer to such standards to facilitate the review of the application. 

There is no need for a new medical device to be identical to the existing one to be eligible for approval under the 510(k) framework. Usually, the differences appear due to the different technologies used, so the approach to be applied when determining substantial equivalence should be quite flexible. 


The 510(k) Review Standard 

The authority further describes in detail the approach to be applied about 510(k) applications submitted and also outlines the main differences with the review process undertaken under other frameworks (in particular – the PMA). For instance, the Agency states that the 510(k) review standard is comparative, whereas the PMA standard relies on an independent demonstration of safety and effectiveness. However, the general principles related to safety and effectiveness are applicable for all frameworks and pathways. 

When reviewing the application, the FDA will start with identifying whether the new medical device submitted for review could be considered substantially equivalent to the one already placed on the market. All the differences between both devices would be subject to rigorous assessment to identify whether they are significant enough to consider both devices as different products. 

First of all, the Agency will assess the intended use and indications for use. Then, attention will be paid to the technological characteristics, which cover the design, materials used, and other aspects which will be considered in the context of safety and effectiveness. 

Thus, the main difference between 510(k) and PMA frameworks is that the first one is based on a comparison of two devices, while the second is based on demonstrating that the new device meets any applicable requirements. However, in both cases, FDA’s review decision reflects a determination of the level of control necessary to provide a “reasonable assurance of safety and effectiveness”. At the same time, the evidentiary standard to be applied will be different. Under the 510(k), the authority will be mostly focused on identifying the differences between two devices, and also assessing the way these differences would impact the safety and effectiveness of the new product. Consequently, the scope of evidence to be provided would depend on the significance of the differences identified. 


The Least Burdensome Approach 

It is also important to mention that to reduce the unneeded regulatory burden and simplify the procedure to be followed when placing new medical devices on the market, the least burdensome approach is applied. Such an approach has been introduced by the FDA Modernization Act of 1997 (FDAMA). According to the respective provisions, an applicant should be asked to provide only the information that is reasonably necessary to decide on substantial equivalence. The applicable legislation prescribes that the term “necessary” stands for the minimum required information that would support a determination of substantial equivalence between a new device and a predicate device. 

In summary, the present FDA guidance provides additional details regarding the 510(k) framework and its specific features. The document also provides a comparison to the PMA framework to assist medical device manufacturers in interpreting and following the respective regulatory requirements. 



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