The new article describes in detail another type of submission – a real-time 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 the submissions required in case of changes to the medical devices already placed on the market under the premarket approval (PMA) framework. In particular, the document describes in detail various types of submissions and explains the way the determination on a specific supplement to be submitted should be made. 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 and are not intended to introduce new rules or impose new obligations the parties involved should follow. Moreover, an alternative approach could be applied, should such an approach be in line with the existing legislation and has been agreed upon with the authority in advance.
Real-Time Supplement: Key Points
The scope of the guidance covers, inter alia, the aspects related to a “real-time supplement” which, according to the applicable legislation, stands for a supplement to an approved premarket application or premarket report under section 515 that requests a minor change to the device, such as a minor change to the design of the device, software, sterilization, or labeling, and for which the applicant has requested and the agency has granted a meeting or similar from to jointly review and determine the status of the supplement”. It is also important to mention that the said type of submission is described in detail in a separate guidance document issued by the FDA. The present guidance outlines the key aspects the authority takes into consideration when determining the applicability of a real-time supplement depending on the changes to an existing device and their regulatory nature. For this purpose, the authority provides several examples of changes and describes the approach to be applied.
Minor Modification to Correct Battery Failures
The first example describes the situation when the authorization holder makes minor modifications to a medical device already placed on the market to fix a battery failure issue. In such a case, bench testing undertaken with the initial device will be sufficient, and its results could further be used to substantiate the claims regarding the device. Apart from this, a party responsible for the device would only have to provide additional testing data addressing the matters related to electrical engineering as the only aspect affected. Hence, in such a case, a real-time supplement will be appropriate for these changes.
Alternative Sterilization Method
The second example describes a situation when the manufacturer decides to make changes to sterilization methods used by adding a new one, apart from the initial one already approved by the authority. In such a case, validation testing should take place to demonstrate compliance with the applicable requirements in terms of sterilization level. The submission should be also accompanied by supporting data addressing sterilization-related matters. As in the previous case, a real-time supplement could be used.
Storage Temperature Change
Another example provided by the FDA describes a situation when the medical device manufacturer decides to expand the temperature limits within which the product should be stored to ensure that all the characteristics remain intact, and the product retains its safety and effectiveness. According to the guidance, this will be considered a minor change to the storage conditions and labeling of the product. In such a case, the applicant would have to provide stability data demonstrating that the higher temperature would not impact adversely on the device and its characteristics. The scope of testing data to be provided could be limited to the changes themselves. Hence, a real-time supplement would be admissible in this case as well.
Extended Shelf Life
A similar approach should be applied in case the medical device manufacturer decides to extend the shelf life of the product. In this case, the manufacturer would have to submit the results of accelerated and long-term testing conducted to assess whether the product remains as safe and efficient as it should be within the whole extended shelf life. The said change would also be considered a minor one, and stability studies would be required. As in previous cases, the scope of supporting data the authority will expect to receive would be limited to the particular aspects subject to changes. Thus, a real-time supplement could be applied.
Component Offered as Stand Alone System
The document also provides an example of when the manufacturer decides to offer a component of a medical device system as a stand-alone system to be used separately. In such a case, there are no actual changes to the device itself. In this situation, a real-time supplement would also be acceptable.
Alternate Wet Shipping Solution
The real-time supplement could also be submitted in case the authorization holder will decide to use an alternate wet shipping solution for contact lenses – the one that has already been approved by the authority for other lenses. In such a case, the aspects to be considered include the ones related to biocompatibility, as well as compatibility with other lenses, and the actual effectiveness of the new solution.
In summary, the present FDA guidance provides additional clarifications regarding the situations in which a real-time supplement could be used. The document also provides several examples intended to assist medical device manufacturers in understating the approach to be applied.
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