The article provides additional details regarding a 180-day supplement – a specific type of submission to be used in case of significant changes to the existing medical device.
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 modifications to devices subject to premarket approval (PMA). In particular, the document describes the PMA supplement decision-making process – the approach to be applied when determining the particular submission pathway to be followed depending on the changes to the medical device in question and their potential impact on the safety and effectiveness of the device. The document is intended to provide additional clarifications regarding the applicable regulatory framework, as well as recommendations to be considered by medical device manufacturers to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, 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 the existing legislation and has been agreed with the authority in advance.
The scope of the guidance covers, inter alia, the aspects related to a 180-day supplement which, according to the applicable regulations, is a supplement to an approved premarket application or premarket report under section 515 that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling”. As further explained by the FDA, submission of this type will be required in case of significant changes to the device already allowed for marketing and use in the US, provided such changes are expected to impact the safety or effectiveness of the product in question. In this case, the clinical data initially provided when applying for marketing approval should remain valid – in most cases, it would be sufficient to carry out additional preclinical testing. At the same time, in certain cases, additional clinical data could still be required. Such data is usually based on the involvement of a limited number of patients and a trial of reduced duration (when compared to a traditional PMA). Hence, due to the limited scope of data required, the authority finds it suitable to use a 180-supplement instead of a panel-track supplement.
According to the guidance, a 180-day supplement could be admissible in case of the changes to:
- The principle of operation;
- The control mechanism;
- The device design or performance;
- The labeling; and
- New testing requirements or acceptance criteria.
The document also provides several examples demonstrating the said approach and the way it should be followed when applying for marketing approval for a modified medical device depending on the nature of such changes and their potential impact on the safety and effectiveness of the product. Each of the examples addresses a specific type of change.
In case the manufacturer makes minor changes to the design of the device, while the indications for use and patient population remain intact, a 180-day supplement could be used. In such a case, it would be sufficient to conduct mechanical tests addressing the specific aspect that has been changed, while any additional clinical data would not be required.
Modified Chemical Formulation
The second example describes a situation when changes are made to the chemical formulation of a hydrophilic contact lens, and also to the manufacturing process. In such a case, additional preclinical testing will be required, addressing the aspects related to biocompatibility, shelf-life, as well as the general safety and effectiveness of a modified product. These changes would be also subject to a 180-day supplement.
Hardware and Software Modifications
The third example describes the changes to the critical components of a transurethral microwave system, including the changes to the motherboard, operating system, and software. In such a case, comparative bench testing would be required to demonstrate compliance with the applicable requirements in terms of safety and effectiveness. At the same time, additional clinical data would not be required since the treatment parameters and algorithm remain intact. Consequently, a 180-day supplement pathway could be followed.
The fourth example explains the approach to be applied in case of changes to the analyzer, which falls within the scope of in vitro diagnostic regulations. In case the technology the product is based on remains unchanged, additional clinical data would not be required. At the same time, a party responsible for such a product would have to perform new analytical performance testing to assess the impact of the said changes on the overall performance of the device. As in previous cases, a 180-day supplement will be suitable for the above mentioned changes.
Design and Software Modification
Another example provided by the FDA describes the changes to the design and software. In particular, the device in question has a battery of a different type in comparison to the initial device, as well as another display. Since such changes would potentially impact the electrical characteristics of the product, additional preclinical testing will be required. The scope of such changes should cover, inter alia, the aspects related to electromagnetic compatibility (EMC), as well as electrical safety and overall performance of the device. At the same time, since additional clinical data will not be required, a 180-day supplement could be used.
In summary, the present FDA guidance describes in detail the approach to be applied in case of significant changes to a medical device already placed on the market which, however, do not require additional clinical data to be provided, while in certain cases additional preclinical testing will be needed to address the aspects that were subject to changes. According to the guidance, in such situations, a 180-day supplement could be submitted.
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