The new article highlights the aspects related to a specific type of submission – a panel-track supplement.
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 followed by medical device manufacturers when determining the particular type of submission to be filed concerning the modifications to the device they are responsible for. The document is intended to provide additional clarifications regarding the applicable regulatory framework, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. It is also important to mention that provisions of the guidance are non-binding, and are not 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 document describes in detail various types of submissions related to modifications to medical devices placed on the US market and also explains the approach to be applied when determining a particular type of submission to be filed. The scope of the guidance covers, inter alia, the aspects related to a panel-track supplement.
Panel-Track Supplement: Key Points
First of all, the document defines a “panel-track supplement”. According to the guidance, it stands for a supplement to an approved premarket application or premarket report under section 515 that requests a significant change in the design or performance of the device, or a new indication for use of the device, and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness. As further explained by the FDA, the submissions of this type should be filed concerning changes to the indication for use with or without limited new preclinical testing. This includes, inter alia, the changes to the patient population, disease state, or other aspects related to the way the device should be used. Under the general rule, such modifications would also require certain changes to be made to the labeling. Submissions of this type could be also filed in case of changes to contraindications.
Thus, a panel-track supplement should be submitted in case:
- Substantial clinical data (i.e., new clinical data) are necessary to provide reasonable assurance of safety and effectiveness for that change; and
- Indication or contraindication changes generally either do not require or require very limited new preclinical testing (i.e., all or most of the preclinical data previously submitted and reviewed in the traditional PMA are still applicable for the change in indication).
The document further provides several examples illustrating the way the above approach should be applied.
Changes to the Patient Population
The first example describes a situation when the medical device manufacturer modifies the indications for use to expand the scope of patients for which the product could be used. In such a case, new safety concerns arise, even though there were no changes to the device itself. Hence, the reliability test should be performed, addressing the safety- and performance-related aspects. The test conditions should reflect the new intended use to ensure that the important matters are properly covered.
In the above situation, a panel-track supplement will be appropriate, since new clinical data were needed to support the safety and effectiveness of the device and, although some additional preclinical testing was needed to address the new conditions of use, the full battery of preclinical testing was not needed because the device itself was not modified.
According to the guidance, a similar approach should be applied in case of changes to the age of patients and the anatomical location where the product is intended to be used since new clinical data will be required as well.
Another change to the patient population, which would also require new clinical data to be provided, is the addition of pediatric patients as another intended population for which the device in question could be used. In such a case, a panel-track supplement would also be admissible.
Different Surgical Procedures
The fifth example provided by the FDA describes a situation when a new procedure is added to the list of procedures for which the device could be used. Such an addition of a new indication results in the need for a new risk assessment to be conducted due to the additional safety concerns arising. Hence, new clinical data will be required to demonstrate that the device meets the applicable safety and performance requirements when used for a new procedure. In such a case, a panel-track supplement should be submitted.
A similar approach should be followed in case of changes to the conditions of use, and new clinical data would also be required to support the new claims made by the manufacturer concerning the product in question. As in all previous cases, a panel-track supplement will be appropriate for modifications of this type.
Other examples provided in the guidance include, inter alia, the ones related to changes to the specimen (sample) type, and the introduction of a different physiological location. In all such cases, the manufacturer would have to provide additional clinical data to demonstrate the safety and effectiveness of the product. Hence, a panel-track supplement would be suitable.
In summary, the present FDA guidance describes the approach to be applied when determining whether a panel-track supplement is to be submitted concerning the changes made. It is important to mention that this type of submission could be used in situations when there were no changes to the device itself, but there are significant changes to the indications for use or intended use population, resulting in the need for additional clinical data substantiating the modified claims.
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