May 18, 2022

The US Food and Drug Administration has issued new draft guidance to establish a full-blown voluntary program for improving quality-related processes in medical device manufacturing following promising results of a pilot program.

The FDA guidance stems from a pilot undertaken by the agency along with the Medical Device Innovation Consortium (MDIC) in 2018. That preliminary effort was called the Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, or CfQ Pilot Program.

Parameters of the Voluntary Improvement Program for medical devices

The FDA’s Center for Devices and Radiological Health (CDRH) released this draft guidance to describe its participation in the Voluntary Improvement Program (VIP). The VIP, facilitated through the MDIC, evaluates the capabilities and performance of a medical device manufacturer. The practices are appraised by third parties to promote process improvement and improve medical device quality.

Based on the success of the pilot, the MDIC program activities and operations will transition into a permanent program, titled the Case for Quality Voluntary Improvement Program (CfQVIP). The FDA and MDIC collaborated to establish a charter and a governance committee for CfQVIP for the program.

The FDA established its baseline quality requirement for medical device manufacturers in its Compliance with the Quality System Regulation, 21 CFR Part 820. The goal of the new recommendations (which are not requirements) is to go beyond the regulation to “elevate and enhance manufacturing processes and behaviors through which safety of medical devices can be improved,” according to the FDA. The guidance reflects best practices that are voluntary, but recommended, in that they benefit all.

In its Case for Quality published in 2020, the agency explained that one of CDRH’s top priorities “is a focus on high-quality products which will better protect and promote public health.” To that end, the FDA worked with industry, healthcare providers, patients, payers and investors to get feedback from all stakeholders in order to build an effective program. The VIP builds on the structure of the CfQ Pilot Program and includes some of the lessons learned from that test effort.

To be eligible for the VIP, medical device manufacturers must have a history of compliance with the FD&C Act requirements and regulations. They must also submit to a Medical Device Discovery Appraisal Program (MDDAP) and meet specified enrollment criteria.

Third-party appraisals of medical device manufacturing processes

The VIP’s third-party appraisal is designed to provide medical device manufacturers with keen insights about the advantages and weaknesses in their current processes so they can get a good picture of how to improve product performance and quality. The VIP oversees third-party appraisers who evaluate volunteer manufacturers against a series of industry best practices.

These benchmark best practices are derived from the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system. VIP uses a version of the CMMI appraisal tailored to the medical device industry.

The appraisals are a collaborative effort of continuous improvement consisting of quarterly check-ins designed to discuss and report progress and growth – in an effort to improve processes and medical device quality, which can ultimately lead to better outcomes and increased access for patients.

VIP opportunities for qualifying manufacturers

Participating VIP manufacturers agree to share some of the results of their process appraisals with the FDA through the appraiser, who will share only de-identified, aggregate data.

The site visits are not a regulatory inspection and appraisers will not assess compliance with regulations. Appraisers will not collect data or issue a rating or certification.

Potential benefits to VIP participants include:

  • Opportunity for FDA consideration in risk-based inspection planning – While VIP appraisals are not regulatory requirements, the FDA may consider inspection results in risk-based inspection planning.
  • 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 FDA plans to offer VIP participants the option to submit 30-Day Change Notices via a modified submission format for modifications to manufacturing procedures or methods.
  • Opportunity to utilize a modified submission format for PMA and HDE manufacturing site change supplements – The FDA plans to offer participants the option to submit 180-Day Pre-Market Approval (PMA) or 75-Day Humanitarian Device Exemption (HDE) Manufacturing Site Change Supplements via a modified submission format.
  • Opportunity to utilize a modified submission format for PMA and HDE manufacturing modules – The FDA plans to offer participants the option to submit manufacturing modules for a PMA or HDE using a modified submission format for review by FDA staff.

Emergo by UL will post updates on the Voluntary Improvement Program as they become available.

Learn more about medical device manufacturing best practices from Emergo by UL:

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  • Kathryn Burke's picture
    Kathryn Burke

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