The new article describes in detail the aspects related to smart regulation and global harmonization for all the procedures and processes related to placing medical devices on the market. 

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 least burdensome approach the authority intends to apply to reduce the unneeded regulatory burden on medical device manufacturers and other parties involved face when placing new medical devices on the market and, consequently, expand the availability of medical devices, especially the ones based on the novel technologies, while ensuring their safety and effectiveness. 

It is important to mention that FDA guidance documents are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with existing legislation and has been agreed with the authority in advance. 


Smart Regulation 

When applying the least burdensome approach, the authority will continuously reassess the respective regulatory framework to ensure the measures applied are the most efficient ones. It is also stated that the scope of information the authority will request when reviewing the applications could be subject to changes due to the new information becoming available to the FDA. In particular, as specific medical technologies become better understood from a scientific and clinical perspective, FDA should periodically assess the appropriateness of data requests in premarket submissions, evaluate premarket and postmarket balance, determine whether devices are candidates for reclassification, and implement changes where appropriate. In this way, the authority will be able to focus its regulatory efforts on the aspects that are the most important in terms of public health protection. The authority will also issue additional guidelines to inform the industry about such changes in the approaches applied. 

As a part of the above process, the authority reconsiders whether certain types of medical devices should undergo a rigorous premarket assessment before being allowed for marketing and use in the country. In this respect, certain Class I and II medical devices are exempted from the requirements set forth under the 510(k) framework. The authority also publishes a list of medical devices for which a 510(k) is not required.

Global Harmonization

The authority acknowledges the global harmonization and regulatory convergence which takes place nowadays. In the course of this process, regulatory recommendations or requirements across different countries or regions become aligned over time using international guidance documents, consensus standards, policies, and procedures. These processes should also be reviewed in the context of the least burdensome approach and the way it should be applied. The authority will align its processes and principles with the ones adopted in other jurisdictions as long as such alignment is reasonable.

It is also stated that the least burdensome principles will also be considered when applying the FDA-recognized voluntary consensus standards medical device manufacturers may refer to to demonstrate compliance with the respective requirements in terms of safety and effectiveness. The use of such standards also improves cooperation between the regulating authority and interested parties. Application of the same standards allows for aligning the regulatory approaches applied in different jurisdictions concerning medical devices, which also contributes to the overall reduction of the regulatory burden medical device manufacturers face when placing their products on the markets in different countries.

In case there is no consensus standard to be applied, a scope of documentation and information the authority will need to assess includes the test protocols and data reports containing important safety information- and performance-related matters. It is further explained that by providing a declaration of conformity to FDA-recognized standards with explicit valid and reliable testing methods, applicants and FDA may not need to discuss whether test methods are scientifically valid and can focus their resources on reviewing the test results; while when consensus standards include both explicit test methods and either performance limits and/or acceptance criteria, a declaration of conformity can potentially replace the submission and review of both the test methods and complete data in a premarket submission. According to the guidance, in the case of generic types of medical devices, the authority will accept declarations of conformity referring to consensus standards even without the evidence provided (in the form of testing data). The aspects related to the use of voluntary consensus standards in the context of premarket applications are further described in a separate guidance document issued by the FDA.

As a part of harmonization efforts, FDA also takes into consideration the recommendations developed by the International Medical Device Regulators Forum (IMDRF), a voluntary association of national regulating agencies in the sphere of medical devices collaborating for further improvement of the regulatory framework. In the course of such activities, FDA participates in the development of a unified approach to regulatory submissions to facilitate and streamline the processes associated thereto. Apart from this, the US authority is involved in workgroups dealing with matters related to clinical evaluation or regulations for Software as a Medical Device.

The document also mentions the Medical Device Single Audit Program (MDSAP) – a program that applies the least burdensome principles by allowing for one audit to satisfy the requirements of multiple regulatory jurisdictions. In such a way, the overall reduction of the regulatory burden faced by the medical device manufacturers is to be achieved, since the number of regulatory audits or requests would be less in comparison to a situation when each national regulating authority makes its requests.

In summary, the present FDA guidance describes the “smart regulation” approach the authority intends to apply to make sure the regulatory measures are the most efficient ones. The document also provides an overview of the harmonization efforts the authority undertakes as a part of its cooperation with other national regulatory agencies.


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