The article provides an overview of the regulatory policy related to the Abbreviated 510(k) Program and highlights the key points associated thereto.
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 Abbreviated 510(k) Program – one of the pathways to be used when placing medical devices on the market. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance. The authority also mentions that the present document is intended to replace the initial guidance dedicated to the matter, issued by the FDA earlier in March 1998.
According to the guidance, recommendations provided therein are intended to describe an alternative approach medical device manufacturers may use when demonstrating substantial equivalence for the products they are going to place on the US market. The new framework described in the guidance is intended to facilitate and streamline the application review process by reducing the regulatory burden.
The document also contains references to the voluntary consensus standards medical device manufacturers may use to demonstrate compliance with the applicable regulatory requirements.
Under the general rule, in case of a medical device intended to be placed on the market, a 510(k) submission should be filed at least 90 days before the device will be made available on the market. The Abbreviated 510(k) Program described in this guidance was initially introduced by the FDA in 1998 to make the submission preparation and review process more efficient. At the same time, the authority additionally emphasizes that the said pathway is not intended to make any changes to the regulatory requirements set forth under the existing regulatory framework. For additional aspects, the authority refers to another guidance document dedicated to the Refuse to Accept Policy for 510(k)s.
The Abbreviated 510(k) Program: Key Points
As it is mentioned in the guidance, FDA believes that, within the Abbreviated 510(k) Program, the use of guidance documents may facilitate the review of 510(k)s through a reliance on“summary reports” that briefly describe and summarize the testing performed to support the submission as recommended in relevant guidance document(s). The FDA further explains that the said reports summarize the device description, the manufacturer’s device design requirements, risk management information, and a description of test methods used to address performance characteristics. The authority states that in case medical device manufacturers would follow the recommendations provided in the FDA guidance documents when preparing the submissions, it will be easier for them to make such preparations, while it would be also easier for the authority to review them.
The concept of special controls was introduced by the Safe Medical Devices Act of 1990. According to the said document, special controls stand for those controls, such as performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions that provide reasonable assurance of the device’s safety and effectiveness. In the context of the Abbreviated 510(k) Program, the authority believes that providing summary information concerning the way special controls are used to address specific matters would make it easier to prepare and review the submissions related to the new medical devices intended to be placed on the market.
Thus, an Abbreviated 510(k) approach applies in case the submission is based on at least one of the below elements:
- FDA guidance document(s);
- Demonstration of compliance with special controls for the device type, either in a device-specific classification regulation or a special controls guidance document; and/or
- Voluntary consensus standard(s).
The authority further explains that the application submitted under the Abbreviated 510(k) Program should contain all the necessary information as set forth under the respective regulation. In particular, such a submission should contain, inter alia, a summary report mentioning all the FDA guidance documents taken into consideration when demonstrating substantial equivalence. Furthermore, the applicant should provide sufficient details about any deviations from the recommendations provided in such guidance documents, or methods described therein.
In the case the manufacturer refers to an applicable voluntary consensus standard, it will be also necessary to provide a declaration of conformity together with the necessary data demonstrating the way the standard has been used.
According to the document, additional information provided by medical device manufacturers as described herein would be beneficial for facilitating the 510(k) submission review and making the regulatory procedures associated thereto more efficient.
It is also important to mention that in case the authority will find the application submitted under the Abbreviated 510(k) Program ineligible for the said framework, such application will be converted to a Traditional 510(k), and the applicant will be notified accordingly.
In summary, the present FDA guidance describes the approach to be applied when submitting the Abbreviated 510(k) Program. The document highlights the most important aspects to be taken into consideration by medical device manufacturers and outlines the scope of information the authority expects to receive.
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