The article provides an overview of the regulatory measures intended to encourage medical device manufacturers to participate in the improvement of medical devices intended to be marketed and used in the US.
The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other parties involved regarding the regulatory approach suggested. Thus, the provisions described in the present draft guidance could be subject to changes due to new information becoming available to the authority.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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance dedicated to fostering medical device improvement. The document describes the FDA’s activities and engagement with the voluntary improvement program. Once finalized, the guidance will provide non-binding recommendations to be considered by medical device manufacturers and other parties involved. The authority also mentions 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.
In particular, the document describes the FDA’s approach toward its participation in the Voluntary Improvement Program (VIP). According to the guidance, the VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals and is intended to guide improvement to enhance the quality of devices. The said framework is based on the pilot projects launched by the FDA earlier in 2018. At the moment, the VIP pathway is only available for the parties involved in manufacturing products subject to regulation by CDRH.
As it is further explained by the FDA, earlier in 2016-2017 the quality of medical devices and the safety of patients were determined as the strategic priorities. For this purpose, the authority conducts ongoing assessments and evaluations of compliance with the applicable regulatory requirements of all the parties involved in the medical device manufacturing process. This includes, inter alia, ensuring compliance with the Quality System Regulation, 21 CFR Part 820. For this purpose, the authority collaborates with numerous stakeholders.
Voluntary Improvement Program: Key Points
As it was mentioned before, VIP is a specific framework intended to improve the overall quality of medical devices marketed and used in the US. The authority additionally emphasizes that the program is voluntary, consequently, medical device manufacturers are not obliged to participate in it. The program is based on the engagement of third-party assessors visiting the manufacturing site and validating the manufacturing processes and procedures against industry best practices. Based on the results of such evaluation, particular opportunities for improvement should be identified. It is important that in the context of the program some of the information could be shared with the authority as well.
Thus, the visits conducted by third-party appraisers are not considered regulatory inspections. As it is stated in the document, they are neither collecting the evidence nor making regulatory observations. Hence, these actions would not impact the company’s certification.
According to the guidance, the main opportunities the program participants will benefit from are the following:
- Opportunity for FDA Consideration in Risk-Based Inspection Planning – the results of third-party inspections could be considered by the FDA when planning on-site inspections.
- Opportunity to Utilize a Modified Submission Format for Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) 30-Day Change Notices for Modifications to Manufacturing Procedures or Methods of Manufacture – the program participants will be allowed to submit 30-Day Change Notices regarding the changes to the manufacturing process. However, in certain cases, the review timelines could be extended.
- Opportunity to Utilize a Modified Submission Format for PMA and HDE Manufacturing Site Change Supplements (the authority allows the use of a specific approach as well).
- Opportunity to Utilize a Modified Submission Format for PMA or HDE – Manufacturing Modules.
At the same time, the authority also mentions that the program and regulatory framework associated thereto could be subject to changes based on the new information becoming available to the FDA in the course of its application. Thus, the authority intends to analyze the experience and take further steps to improve the program.
Voluntary Improvement Program Operations
According to the guidance, the Voluntary Improvement Program is based on the use of the CMMI Maturity Model for Development Version 2.0 and the Medical Device Discovery Appraisal Program (MDDAP) in the course of the assessments covered by its scope, which will be determined in the course of consultations with the representatives of the manufacturer responsible for the facilities subject to the assessment. The information they will provide will be used to identify the key points to be addressed in the course of the appraisal, and also to decide on the specific strategy to be applied. This information will be also used to identify the spheres that could be improved. As is further explained by the FDA, this is intended to provide the participating manufacturer with a rich dataset and granularity that reflects its organizational performance against the practices outlined in the maturity model, and a roadmap to improve performance against the practices outlined in the maturity model, and a roadmap to improve performance, increase quality, and enhance value; while FDA also benefits by receiving a summary of the firm’s results and aggregated results across all participating manufacturers.
The document also outlines the specific criteria to be considered when determining the eligibility of a particular medical device manufacturer for participation in the voluntary improvement program. According to the guidance, specific criteria should be applied to the medical device manufacturer in general and the manufacturing facilities in question in particular. The final confirmation will be provided by the authority. As it is stated by the FDA, to be eligible for the VIP, a manufacturer is expected to have a history of complying with the applicable requirements of the FD&C Act and its implementing regulations. At the same time, in certain cases, the authority will consider approving the manufacturing sites that have no previous compliance history. However, such entities wouldn’t be able to benefit from some of the opportunities the program provides.
It is expected that the manufacturing site participating in the program will:
- Receive an annual appraisal;
- Engage with appraisers and commit to the proposed appraisal process;
- Perform a quarterly progress check-in with lead appraisers;
- Submit quality performance measures according to the criteria outlined in the CMMI system and appraisal method;
- Proactively notify FDA regarding product safety issues or recalls following all current regulatory requirements, including reporting.
In summary, the present FDA guidance provides an overview of the regulatory framework associated with the Voluntary Improvement Program introduced to improve the overall quality of medical devices placed on the market. The document outlines the key benefits of the program and describes the eligibility criteria to be considered.
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