The article provides a general overview of the guidance document dedicated to the approach the US regulating authority intends to apply in order to facilitate medical device improvement while ensuring compliance with the applicable regulatory requirements.
Table of Contents
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 fostering medical device improvement.
In particular, the document describes the FDA activities and engagement with the Voluntary Improvement Program. The guidance provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration in order to ensure compliance thereto.
At the same time, it is important to mention that US FDA guidance documents 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 legislation and has been agreed with the authority in advance.
The present guidance is based on the draft issued earlier in May 2022.
Introduction
The FDA’s Center for Devices and Radiological Health (CDRH) issued a new guidance describing its policy concerning participation in the Voluntary Improvement Program (VIP).
This VIP initiative, is facilitated under the umbrella of the Medical Device Innovation Consortium (MDIC), has a primary objective to thoroughly evaluate and potentially enhance the performance and practices of medical device manufacturers through rigorous third-party appraisals.
This program is based on an earlier initiative, the FDA’s 2018 Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program).
The authority additionally emphasizes that not all manufacturers can participate in VIP; only a select group that falls under the supervision of the CDRH is eligible for this.
Background and History
The document further provides a brief overview of the historical development associated with the VIP.
In general, the CDRH has a vision for the future development of the medical device ecosystem.
This vision is based on the production of devices with exceptional features and the implementation of manufacturing practices that are aligned with ensuring patient safety to the extent possible.
This commitment to quality was also highlighted in the CDRH’s strategic focus for 2016-2017, where the authority emphasized the need to promote a robust culture of quality.
As a part of its extensive responsibilities, the FDA is responsible for supervising manufacturers’ compliance with any applicable regulatory requirements, especially the ones related to the device design and the entire production lifecycle.
This covers, inter alia, compliance with the Quality System Regulation, particularly 21 CFR Part 820
To ensure efficient cooperation between the parties involved, the FDA took a collective approach cooperating with multiple stakeholders.
These efforts resulted in the formation of the MDIC public-private partnership, which then subsequently transferred to the CfQ Pilot Program, announced officially in December 2017.
The main purpose of the said regulatory improvements is to establish a comprehensive approach medical device manufacturers can utilize to review and improve the processes that are vitally important in the context of quality assurance and continuous safety of medical devices while facilitating their further development and improvement.
Key Features and Benefits
The guidance further highlights the most important aspects associated with the program and explains their specifics.
According to the guidance, VIP was created by the MDIC in order to emphasize the standards of medical device design, production, and quality assurance.
At the same time, the authority additionally emphasises that despite its important role, the VIP remains to be voluntary in its legal nature, in comparison to the general regulatory requirements.
The entire VIP concept is based on the leading role of third-party appraisers. These experts are entitled to assess a manufacturer’s capabilities and performance across the most important spheres and aspects based on the existing best practices.
Once such an assessment is completed, it provides a comprehensive overview of the strong and weak points of the processes and procedures employed by a medical device manufacturer, highlighting the aspects that require further improvement.
Furthermore, an extensive set of data generated in the course of such an assessment would also be used for assessing additional metrics and criteria.
However, as explained by the authority, the VIP is not intended to replace any regulatory inspection or audit – as it was mentioned before, the VIP is fully voluntary in its legal nature.
The third-party appraisers are not expected to assess the manufacturer’s compliance with the applicable regulatory requirements, nor to provide any formal certification.
The document further outlines the main benefits for medical device manufacturers associated with participation in the VIP. According to the guidance they include, inter alia, the following ones:
- Consideration in Risk-Based Inspection Planning: While the VIP appraisals might not replace or equate to traditional FDA inspections, they can play an important role in influencing the FDA’s judgments during risk-based inspection planning processes.
- Expedited Submission Processes for PMA and HDE: One of the standout benefits for VIP participants is the potential to leverage a streamlined submission process for various manufacturing-related tasks.
This streamlined approach has the potential to result in faster reviews, even though it relies on available resources and the nature of the submission. - Special Provisions for PMA or HDE Manufacturing Modules: Another significant advantage lies in the possibility of submitting manufacturing modules for a PMA or HDE using a specialized submission format, further described in the guidance.
In summary, the present FDA guidance provides an overview of the VIP as a program introduced to facilitate the improvement of all the aspects related to manufacturing medical devices and ensuring their proper quality. The document explains the non-binding, voluntary nature of the VIP and highlights the main benefits associated thereto.
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