The Food and Drug Administration (FDA) has published guidance dedicated to the safety and performance pathway as it applies to medical devices. Due to its legal nature, the document does not establish mandatory rules the industry representatives shall follow. It only provides non-binding recommendations instead.
The present FDA guidance describes the approach related to the Abbreviated 510(k) Program used in the context of demonstrating substantial equivalence. In particular, the document provides an alternative approach to be used if well-understood device types confirm that the device in question meets the applicable safety and performance criteria – the Safety and Performance Based Pathway.
The concept of substantial equivalence is currently set forth under section 513(i)(1)(A) of the Federal Food, Drug, and Cosmetic (FD&C) Act. In particular, the following criteria should be applied when determining substantial equivalence with the medical device already placed on the market (predicate):
- The intended use,
- The technological characteristics,
- The safety and effectiveness aspects.
The information to be provided by the medical device manufacturer should be sufficient to demonstrate that the device in question is as safe and effective as a predicate device.
The present FDA guidance describes the way the Agency determines substantial equivalence. As it is stated in the document, the 510(k) program has been improved significantly in order to meet today’s needs. In the course of such improvements, two special frameworks have been introduced by the FDA: the Special 510(k) program and the Abbreviated 510(k) program. According to the general approach the FDA utilizes, the regulatory burden should be reduced to the lowest extent possible – the information to be provided by the manufacturer should be sufficient for the FDA to be able to assess all regulatory issues associated with the medical device subject to review. The FDA acknowledges that in some cases a comparison through testing creates an unneeded regulatory burden. To avoid this, the FDA has introduced special regulatory frameworks simplifying the regulatory procedures associated with the demonstration of substantial equivalence. This approach will allow the FDA to improve the effectiveness of the review of 510(k) submissions while maintaining compliance with the applicable requirements.
FDA Policy on Safety and Effectiveness
According to the FD&C Act, a substantial equivalence concept is based on the comparison between the medical device subject to review and a similar medical device already placed on the market (predicate). In particular, such a comparison could be based on certain safety and effectiveness. Thus, using the alternative approach, the FDA will evaluate the evidence demonstrating the equivalence of medical devices instead of analyzing the performance of the devices. In accordance with the document, the medical device manufacturer could submit data demonstrating that the device in question meets the performance requirements based on the performance of the predicate device. The FDA also states that the particular performance criteria the medical device should meet are set forth by:
- FDA guidance documents,
- FDA-recognized consensus standards (the standards explicitly recognized by the Agency to be used for making references in the course of application submission), and/or
- Special controls (that are applicable irrespectively the particular 510(k) pathway used by the manufacturer).
The FDA also mentions that the appropriate performance criteria are not always clearly determined.
In accordance with the recommendations provided in the FDA guidance, when determining the applicable performance criteria, the manufacturer shall refer to the performance of the FDA-approved medical device already placed on the market.
The direct comparison between the investigated device and the predicate should be performed under the Traditional or Special 510(k) pathway, or 510(k) Third Party Review Program, while the present FDA guidance describes an alternative approach that could be applied under the Abbreviated 510(k) Program.
According to the general rule, in the course of an Abbreviated 510(k) framework, the manufacturer shall demonstrate conformity to FDA guidance, FDA-recognized voluntary consensus standards the manufacturer may refer to, and/or special controls. When applying the safety and performance based pathway described in the present FDA guidance, the manufacturer will mostly focus on the criteria used to determine the predicate.
The FDA also outlines the key applicability criteria for the safety and performance based pathway, namely:
- The medical device in question has the same indications for use and technological characteristics as a predicate.
- The performance criteria of the medical device subject to review align with the ones for similar medical devices already placed on the market.
- The medical device in question meets any and all performance criteria.
According to the FDA guidance, when using the safety and performance based pathway, the manufacturer may utilize any applicable testing methodology, while the FDA reserves the right to provide non-binding recommendations regarding the particular methodology to be applied. The FDA intended to describe all applicable performance criteria that could be used in the context of the safety and performance based pathway in the appropriate guidance documents to be issued by the FDA later.
The document also provides details regarding the applicability of the safety and performance based pathway. In particular, the FDA states that if the performance criteria are not sufficient to evaluate all aspects that are important due to the specifics of the device subject to review, the aforementioned framework would not be applicable. Other approaches, such as Traditional, Special and Abbreviate frameworks could still be applied.
Safety and Performance Based Pathway Application Process
The FDA guidance on the safety and performance based pathway also outlines the main points to be considered by the medical device manufacturer intending to place its device on the US market under the appropriate framework. These points include, inter alia, the following ones:
- The FDA will publish and maintain a detailed list of types of medical devices that are admissible in the context of the aforementioned framework.
- When submitting an application, the manufacturer shall also indicate the predicate device(s) based on the intended use and technological characteristics. In particular, the FDA states that technological characteristics should not raise different questions of safety and effectiveness from the predicate device.
- If there are any doubts regarding the admissibility of the particular medical device in question for the safety and performance based framework, the manufacturer may contact the FDA to obtain additional clarifications. In certain cases, the FDA may require the manufacturer to provide additional information if it is reasonably necessary to make a correct determination.
- Besides the list of admissible device types, the FDA is also going to outline the performance criteria applicable to each type of medical device.
Summarizing the information provided hereinabove, the FDA guidance on the safety and performance based pathway describes an alternative approach introduced by the FDA to simplify the regulatory procedures associated with placing medical devices on the market and improving review procedures.
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