The article highlights the aspects related to benefit-risk considerations and key points associated thereto.
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The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to medical devices with indications associated with weight loss.
In particular, the document addresses the clinical study and benefit-risk considerations.
Once finalised, the document will provide an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto.
At the same time, it is important to mention that provisions of the present guidance are non-binding in their legal nature, nor are they 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 regulatory framework and has been agreed with the authority in advance.
Benefit-Risk Considerations: Key Points
The FDA determines the assurance of safety and effectiveness of medical devices by applying different review pathways, such as PMA, De Novo classification, and 510(k) premarket notification.
The core of this assessment is based on weighing the probable health benefits of using the device against potential risks of injury or illness.
This benefit-risk profile is often compared to a valid predicate – a similar medical device already placed on the market.
To assist the FDA in this decision-making, device manufacturers should provide valid scientific evidence.
This can be clinical investigations, non-clinical data, or other relevant information the authority will assess when making such a decision.
According to the guidance, the FDA’s primary concern is whether the device will function as claimed under the conditions recommended.
Assessing Benefits and Risks
When evaluating the advantages of devices, the FDA looks at the types, magnitude, probability, and duration of the benefits.
On the other hand, when assessing the risks, the FDA considers the severity, type, rate, and duration of harmful events linked to the device’s use.
Other factors, such as patient preferences, the nature of the disease, available alternative treatments, risk mitigation measures, and more, also play a role in this assessment.
For devices meant to aid in weight loss, special considerations should be taken into account as well.
As explained by the FDA, the key factors include the actual amount of weight loss due to the device, improvements in associated health issues like hypertension or dyslipidemia, and the overall enhancement in the quality of life.
On the risks side, the FDA evaluates the severity and duration of adverse events, any permanent changes the device might bring about in the body, risks related to device placement or removal, and more.
There are multiple technologies and techniques in the market aimed at weight loss. These diverse approaches can lead to various outcomes, such as different durations of device implantation, adverse event profiles, and weight loss amounts.
The FDA recommends how it plans to consider these outcomes, especially adverse events, about the device’s benefits.
The FDA recommends an adverse event classification based on the Clavien-Dindo Classification of Surgical Complications.
This classification grades the severity of device and procedure-related adverse events. This system has been modified to be more pertinent to weight loss devices.
For instance, the revised Grade I includes over-the-counter medications, while Grade II encompasses all other prescription medications.
The FDA also considers other factors, such as the reason for hospitalization and the risk of diagnostic procedures, when evaluating the overall benefit-risk for these devices.
Balancing Weight Loss and Adverse Events
The FDA’s evaluation of the tolerability of adverse events in light of varying weight loss degrees is based on outcomes from previous panels, feedback from external experts, and public comments.
The indications for weight loss depend on the extent and duration of weight loss demonstrated in a clinical study.
If devices are used for less than six months or don’t meet the weight loss criteria outlined in the guidance, they might be indicated for weight management instead of obesity treatment.
The duration for which the device is used can vary depending on the device’s nature.
For implantable devices, it stands for the total time the device remains in the body. For devices that cause permanent anatomical changes but are used temporarily, the duration is the time point at which weight loss is measured post-device use.
For recurring-use devices, the duration is the time the device is used before measuring the results.
Consider a device temporarily placed in the stomach.
A clinical study with a treatment group and a sham group was conducted. After six months, the devices were removed, and the weight change was measured.
The results showed that the treatment group lost significantly more weight than the sham group. Based on guidance, this weight loss would be termed “short-term limited weight loss.”
Application Details
According to the guidance, interested entities can apply to be part of the program via the IDAP pilot application, available on GovForms.
Important dates include the pilot’s launch on 19th September 2023 and its conclusion on 29th October 2023.
The first results from this pilot will be communicated in December 2023, with more details to be released after January 2024.
As further explained by the authority, multiple benefits are available for those who complete the application process.
These successful applicants will have access to multiple tools tailored to speed up the development and integration phases of their devices.
Notably, they will receive both regulatory and testing support from MHRA. Additionally, NICE will undertake feasibility studies for the product, a move that will significantly smoothen its integration into the UK’s public health infrastructure
Conclusion
In summary, the present FDA guidance provides an overview of the benefit-risk approach utilized by the authority when assessing medical devices with weight loss indications. The document outlines specific aspects the authority will pay attention to and also describes the key considerations associated with potential risks and benefits.
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