The new article describes in detail the activities to be undertaken in the context of participation in the Voluntary Improvement Program.
The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other parties involved regarding the regulatory approach suggested. Thus, the provisions described in the present draft guidance could be subject to changes due to new information becoming available to the authority.
The Agency will accept comments within two months from the date the document has been initially published. Once finalized, the document will provide additional recommendations and clarifications on the matter.
Due to their legal nature, guidance documents do not introduce any requirements themselves. The approach described therein should be taken into consideration by the medical device manufacturers or other parties engaged in operations with medical devices in the context of achieving and sustaining compliance with the applicable regulatory requirements set forth by the current legislation. Additionally, the Agency states that an alternative approach could be applied, provided such an approach has been approved by the authority in advance.
Thus, the present FDA guidance provides suggested recommendations for the design of feasibility and early feasibility clinical studies for certain medical devices. These recommendations are mostly based on existing clinical practice guidelines.
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 Voluntary Improvement Program (VIP), a special framework intended to facilitate the improvement of the overall quality, safety and performance of medical devices intended to be marketed and used in the US. Provisions of the guidance are non-binding and are not intended to introduce new rules or impose new requirements, but to provide additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved. Furthermore, it is explicitly stated that an alternative approach could be applied, provided such an approach is in line with existing legislation and has been agreed with the authority in advance.
The document describes, inter alia, the process flow for participation in the program which includes the following steps:
- An interested party should apply via the special portal.
- The regulating authority will review the application within 5 calendar days from the date of submission and confirm eligibility. Should the authority decide to reject the application due to the ineligibility with the participation criteria, the applicant will be notified accordingly.
- The third-party appraisal program informs the authority about the agreement reached with the medical device manufacturer, and also provides the appraisal schedule agreed by the parties.
- The parties should coordinate and conduct the assessment based on the pre-agreed scope within 90 calendar days from the date the initial confirmation was provided by the authority.
- An appraisal summary is to be provided to the authority by the third-party appraisal within 30 calendar days from the date the appraisal has been completed.
- The manufacturer participating in the program takes part in regular meetings to discuss the progress.
- The parties agree on further actions to be taken as a part of the follow-up on an annual basis and inform the authority about the plan agreed.
The guidance also describes in detail the activities the authority is going to undertake in the context of the Voluntary Improvement Program. According to the guidance, the FDA maintains representation on the VIP governance committee and provides input to overall program operation and changes, to ensure that VIP continues to align with FDA’s expectations of improving participating manufacturing sites’ capability and performance and that VIP provides value to industry stakeholders. In particular, the applicable framework outlines the scope of information to be provided to the authority by a third-party appraisal, which the authority intends to consider in the benefit-risk considerations FDA routinely uses to inform planning, improve FDA resource allocations, improve review efficiency, and inform risk-based inspection planning, for firms that demonstrate capability and transparency around their manufacturing and product performance.
As further explained by the FDA, the authority intends to:
- Interact with the manufacturer to ensure that the potential safety issues are duly resolved;
- Interact with the manufacturer regarding the issues identified in the course of the appraisal. The authority additionally emphasizes that if there is no resolution for such issues, the appraisal should end, and the participant may no longer continue to participate in the program.
Regulatory Requirements and Obligations
According to the guidance, participation of a medical device manufacturer in the Voluntary Improvement Program does not impact its obligations set forth under the general rules and regulations. Neither does it impact the authorities FDA has concerning the manufacturer under the applicable legislation. In particular, it is stated that the authority would still be entitled to take enforcement actions, should it be reasonably necessary to ensure the public health protection and safety of patients, while medical device manufacturers participating in the program would still be obliged to follow the applicable regulatory requirements set forth by the respective legislation. It is also important to mention that the information provided to the FDA in the context of participation in the Voluntary Improvement Program could not be used to substitute the evidence necessary in the course of an inspection conducted by the authority itself.
As further explained by the authority, if issues (such as safety) are brought to FDA’s attention during a firm’s participation in the VIP program, FDA intends to collaborate with participating manufacturing sites first to mitigate the impact of the issue, then to identify and implement the most effective and efficient resolution which may include an action plan and regular communication. Hence, to ensure that all the issues are duly resolved, the program participant should contact the respective Offices responsible for the products in question. Should the authority determine that the manufacturer participating in the program has already completed all the steps that are sufficient to mitigate the risks associated with the issues identified, participation in the program could be continued. At the same time, should the authority determine that there is no significant progress, while the situation itself could result in the harm caused to the patients who are exposed to the respective risks, the authority is entitled to limit the opportunities available to the participant in the context of the Voluntary Improvement Program, or even require the participation to be suspended.
Withdrawal and Removal
The document further describes the grounds and procedures for removal from participation in the Voluntary Improvement Program after the initial acceptance. First of all, it is important to mention that participation takes place voluntarily, consequently, the participants are entitled to withdraw from participation at any time. For this purpose, a participant interested in withdrawal should provide the appropriate notice to a third-party appraisal body or the authority itself. As it was mentioned before, this would impact the ability to benefit from the opportunities available under the VIP framework. At the same time, it would be still possible to apply for participation again at a later stage.
As described in the guidance, one of the main purposes of the VIP is to establish an efficient collaboration between the medical device manufacturer and the authority to ensure that all the issues identified in the course of an appraisal are resolved successfully without undue delay. However, should the authority decide that the manufacturer does not cooperate properly, nor takes all the steps necessary to ensure the quality and safety of medical devices, the FDA may decide to suspend participation and remove the manufacturer from the program.
In summary, the present FDA guidance describes in detail the most important aspects related to participation in the Voluntary Improvement Program. In particular, the document addresses the matters related to the application process, and also the situations when participation in the program could be suspended either by the authority, or the manufacturer itself.
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