The new article addresses the aspects related to the voluntary improvement program introduced by the US regulating authority.
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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 guidance document dedicated to FDA activities and engagement with the Voluntary Improvement Program (VIP) in the context of fostering medical device improvement.
The document 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, provisions of the 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.
In particular, the document describes in detail the Voluntary Improvement Program operations and highlights the key points to be considered by medical device manufacturers and other parties involved.
According to the guidance, the Voluntary Improvement Program is an initiative that employs the Medical Device Discovery Appraisal Program (MDDAP), a specialized version of CMMI Performance Solutions.
The core objective of the VIP is to rigorously assess the performance and capabilities of medical device manufacturers.
In particular, the current practices are compared to the ideal practices proposed by the maturity model.
The authority additionally emphasizes that this program is not intended to check regulatory compliance.
Instead, it provides for a rigorous assessment of whether the business processes of a manufacturer are appropriate for achieving their stipulated business objectives, with an emphasis on continuous quality improvement while ensuring the proper quality and safety of medical devices.
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.
ISACA and MDDAP
First of all, the document highlights the aspects related to ISACA and its participation in the processes and procedures related to the improvement pathways.
According to the guidance ISACA as an independent authority plays a vitally important role in the administration of the MDDAP.
This includes such tasks as certifying third-party appraisers, overseeing the results from these appraisals, and undertaking an in-depth analysis of the collated data.
Appraisers, in their capacity, undertake a detailed study, collecting data on the manufacturer’s work units, the range of products, the total number of employees, and the manufacturing volume.
This comprehensive data collection is intended to generate the data they will use for tailoring their evaluation strategy.
Moreover, it is used as a basis for comparing how individual participants follow the best practices and helps pinpoint areas that offer room for improvement.
Benefits for Stakeholders
The document further outlines the main benefits for the parties involved associated with participation in voluntary improvement initiatives supported by the FDA.
According to the guidance, for manufacturers, the program described in the document offers invaluable feedback concerning their organizational performance.
At the same time, the FDA creates a comprehensive summary covering both individual entity data and aggregated information, providing a broader view of the industry standards.
VIP Eligibility Criteria
The guidance also describes specific criteria to be applied when determining eligibility for the VIP.
As explained by the FDA, in order to be a part of the VIP, manufacturing sites should meet certain eligibility criteria, both for enrollment and continued participation.
It is important to mention that one of the key criteria is the necessity of undergoing an MDDAP appraisal.
It is then for the FDA to conduct a rigorous review and subsequently confirm the eligibility of an applicant for enrollment in the VIP.
Existing members of the CfQ Pilot Program are automatically incorporated into VIP, with a provision to opt out.
According to the guidance, the general expectations for VIP eligibility are based on the manufacturer’s compliance history with the FD&C Act and its implementing regulations.
However, there is room for certain flexibility.
The FDA, recognizing the diverse nature of the industry, is open to considering manufacturers without a compliance track record.
This includes component manufacturers and firms that may not meet all eligibility factors. At the same time, it is explicitly stated that these companies may have limited access to some VIP opportunities.
Manufacturing sites that participate in VIP are expected to meet a well-defined set of expectations.
This includes, inter alia, annual appraisals, commitment to the appraisal process, and proactive engagement with appraisers.
Furthermore, there is an emphasis on quarterly check-ins with lead appraisers and the consistent provision of quality performance metrics, outlined within the CMMI system.
VIP Process Flow in Detail
To assist medical device manufacturers interested in participation in the aforementioned program, the document also provides a detailed description of the VIP process flow. According to the guidance, the said process comprises the following steps:
- A manufacturing site interested in participation submits the appropriate application.
- The application is subsequently relayed to the FDA by the third-party appraisal program.
- The authority reviews the application with a 5-day limit
- Following this, the appraisal contract details and schedules are communicated to the FDA.
- The appraisal itself takes place within 90 days from the point of enrollment confirmation.
- Upon completion of the appraisal, a detailed summary is dispatched to the FDA within a 30-day window.
- The subsequent steps involve quarterly check-ins, the provision of performance metrics, and meticulous planning for follow-up appraisal activities on an annual basis.
In summary, the present FDA guidance describes in detail specific matters associated with participation in the voluntary improvement program that medical device manufacturers should consider before applying.
The document outlines the main eligibility criteria and also provides additional clarifications concerning the main steps.
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