The US Food and Drug Administration (FDA) has issued draft guidance describing the agency’s participation in a permanent medical device Voluntary Improvement Program (VIP) that uses third-party appraisals to evaluate manufacturing practices.
The VIP is operated by the Medical Device Innovation Consortium (MDIC) and builds on the experience of the Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program.
As in the pilot program, VIP oversees third-party appraisers who evaluate industry participants using best practices in the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system. VIP uses a version of the CMMI appraisal that is appropriate for the medical device industry, covering 11 practice areas including estimating, planning, and configuration management.
Based on the evaluation, VIP identifies the manufacturer’s strengths and areas for improvement and some de-identified, aggregate information is shared with FDA.
“The site visit and/or analysis is not intended to be a regulatory inspection or an audit, and appraisers do not assess the firm’s compliance with applicable regulatory standards. Appraisers do not collect evidence during their site visit, and do not make regulatory observations or findings. Although the VIP produces information conveyed to both the firm and to FDA, it does not issue a rating or a certification,” the agency wrote in the draft guidance.
In 2018, FDA and the MDIC launched a voluntary pilot program at medical device manufacturing sites in which certified third-party teams would perform quality system appraisals of various processes associated with quality and performance objectives. During the pilot, participating sites agreed to work with FDA’s Center for Devices and Radiological Health (CDRH) and submit baseline metrics after the appraisal to monitor progress on a quarterly basis. The device makers covered their own appraisal costs (RELATED: FDA Details New Manufacturing Quality Pilot Program, Regulatory Focus 15 January 2018).
The pilot had 46 active participating sites and more than 80% of participants surveyed said that the appraisal had a direct value related to improving product quality. Based on the results of the pilot, it is transitioning to a permanent program, called Case for Quality Voluntary Improvement Program (CfQVIP).
Under the draft guidance, participating manufacturing sites that show sustained capabilities or improvements can choose to take advantage of several opportunities including FDA consideration in risk-based inspection planning, use of 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, use of a modified submission format for PMA and HDE manufacturing site change supplements, and use of a modified submission format for PMA or HDE manufacturing modules.
The agency will maintain representation on the VIP governance committee and provide input to program operation and changes. The draft guidance also notes that FDA will engage with participating manufacturing sites to discuss and resolve issues brought to the agency’s attention during an appraisal. “If there is no resolution for such issues, the appraisal should end, and the participant may no longer continue to participate in the program,” according to the draft guidance.