The Food and Drug Administration (FDA), the US medical device regulating authority, has introduced the new regulatory framework for medical devices.
Existing Frameworks: A Short Overview
The Agency published a new framework regulating the procedure of premarket review of the 510(k) medical device applications. It is important to mention that the new Safety and Performance Based Pathway framework extends the existing framework. Before this, there were three main types of premarket review:
The new framework is intended to expand the last one and would apply to specific types of medical devices. All submissions must be submitted in electronic form. The applicant receives the 510(k) application number which allows them to track how the submission is moving through the process.
The Traditional procedure should be applied if a similar device is already present on the market (such a device would be defined as a “predicate”). It is a basic procedure that can apply under almost any circumstances. In this situation, it is necessary to confirm a substantial equivalence (SE) providing that the device that the manufacturer is going to distribute has the same features as another device that is already present at the market. It is also possible to provide this comparison with several different devices. The exact information that must be provided for Traditional procedure is defined by device-specific guidance. The Special and Abbreviated procedures were created when The New 510(k) Paradigm was split into two separate procedures in 2019.
The Special procedure applies when the manufacturer is going to make certain changes to the device that is already present at the market or to file the DeNovo submission (if there are no similar devices at the market) used for entirely new devices. In addition to the substantial equivalence, the Special procedure also relies on design control providing risk evaluation. The process also includes validation and verification procedures utilized to confirm that the device has been constructed in accordance with the initial description and fits the intended purpose. In general, the Special procedure allows the manufacturer to provide a sufficient minimum of the information regarding changes to the own existing device. The FDA provides a list of changes subject to review under the Special procedure. The whole process usually takes up to 30 days from the day the documents are submitted to the Agency, which is much faster than the general 510(k) procedure. If the Agency defines that the Special procedure could not be applied in the particular case, it would transform the submission into the Traditional 510(k) application and the manufacturer would be notified.
The Abbreviated procedure applies to certain submissions based on special regulations and guidance for specific types of devices, confirmation of compliance with special requirements or voluntary consensus standards (the standards recognized by the Agency and allowed to be used by the manufacturers to confirm the compliance). In other words, in this case, the manufacturer provides information on compliance with existing standards and guidelines to simplify and accelerate the review process. Sometimes the manufacturer doesn’t even need to submit data on testing and evaluation and can provide the summary report instead. The report should contain references to the applicable guidelines and standards the devices must comply with. If filing a submission for a Class II medical device, special controls could be applied. Special controls constitute various approaches applicable to ensure safety and performance, including clinical data submission, postmarket surveillance and other similar actions.
The New Framework
The draft guidance published by the FDA outlines performance evaluation criteria and methodology for testing applicable for several types of Class II medical devices. According to the guidance, the new Safety and Performance Based Pathway could be utilized if the device subject to review has features providing the same safety and effectiveness characteristics as the predicate device that is already available on the market. The new device must also comply with the performance requirements set forth by the Agency. It is important to mention that the device must meet at least one of the two factors mentioned above otherwise the manufacturer would have to use another procedure. The FDA is going to issue additional guidelines describing performance criteria applicable for different types of medical devices while all parties involved may send their proposals and suggestions regarding the particular devices. Later the Agency will place a list of devices eligible for the new framework on the website, together with the appropriate guidelines. It is important to mention that the new procedure would apply to the well-understood device types so in filing a submission for an entirely new medical device it would be necessary to use another procedure (in most of cases, it would be DeNovo).
The scope of information necessary to be provided depends on the particular testing methods used to assess the safety and performance of the specific device. The manufacturer would still have to find the device with similar features but at the same time, the device should not be exactly the same – in most cases, it would be sufficient to provide substantial equivalence on the specific aspects. Depending on the particular situation, it would be necessary either to confirm that the device subject to review has features similar to the predicate or to confirm compliance with the performance and safety criteria set forth by the FDA that doesn’t require the direct comparison of both devices.
The Implementation of the New Framework
The Agency states that the new framework is still under development, so substantial changes and amendments could be made if it was found necessary during the evaluation of the first devices. The FDA also accepts feedback that would also be analyzed and used for the improvement of the framework. There are only five types of medical devices available for Safety and Performance Based Pathway, namely:
- Spinal Plating Systems,
- Magnetic Resonance Coils,
- Conventional Foley Catheters,
- Cutaneous Electrodes for Recording Purposes,
- Orthopedic Non-spinal Bone Screws and Washers.
It is also expected that the list of eligible devices would be extended in the future.
As part of the new implementation process, the Federal Food, Drug, and Cosmetic Act was also amended by adding the concept of the “least burdensome” – the principle under which the manufacturer should provide the minimum information reasonably necessary for the Agency to solve the particular case. The new guidance issued by the Agency also includes the list of aspects that should be highlighted in the submission. In particular, it is necessary to provide the declaration of conformity and summary report. The manufacturer would also need to provide the documents containing the detailed description of the device, the information on its labeling, data on biocompatibility and sterilization.
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