MedCon: FDA officials say VIP is ‘win-win’ for agency and industry

COLUMBUS, OH – Representatives from the US Food and Drug Administration (FDA) encouraged companies to take advantage of its Voluntary Improvement Program (VIP), touting its success as a full-time program and the benefits for industry participants.

The agency is “very committed to this program,” Erin Keith, materials engineer, compliance and quality program in the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) at FDA, told attendees at the 2025 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

“[T]here is, as you will note, that there are very few things that we are speaking on in public lately, and VIP is one of them,” she said. “We feel that this is a program that has a lot of win-wins for everybody involved, and that ultimately companies, through continuous improvement, can reap both financial rewards as well as improved products that have a higher quality, higher safety and results in greater availability to good products for Americans.”

A company is eligible for VIP if they have a medical device distributed in the US with a positive inspection history and no official action indicated (OAI) status and are not part of a judicial review. Companies can participate in VIP at any point in a device’s lifecycle.

“[T]he overall intent of this of this program is to improve product quality, safety and availability through a focus on continuous improvement,” Keith said. VIP’s intended result is improved product quality and availability, increased manufacturing performance and value, best practice sharing and investments in improvement, and identification of improvement areas through an appraisals process, she noted.

VIP is not an inspection, and differs from the inspection process in several ways, Kim Kaplan, senior product manager at ISACA, told attendees. Appraisers do not check against the Code of Federal Regulations since that is a prerequisite of the program. “Instead, we'll be focusing on the activities and capabilities that occur within your organization that provide value,” she said.

Instead of focusing on documentation and standard operating procedures, “we focus on having conversations with those individual contributors that are actually doing the work,” Kaplan said.

“As some of you may have experienced in your manufacturing sites, sometimes the way work is done isn't exactly the way the process document is written,” she explained. “We want to get at maybe why that's happening and then identify how that's impacting your business.”

There is also not a focus on addressing gaps or opportunities as seen with a corrective action list, Kaplan noted. “Instead, we want to use these opportunities to drive a discussion about what's going to make the biggest impact in your organization and how these align already with your objectives,” she said.

Experience with VIP

In a 2024 survey of the program that included 362 respondents, Kaplan noted 90% said they had an excellent or above average impression of the appraisal, 95% reported the appraisal identified areas for improved product quality, and 83% said it was a value-add to the organization.

Roseanne Leaupepe, general manager, quality systems at Fisher & Paykel Healthcare, told attendees that VIP has been a positive force in her company.

The three biggest impacts VIP has had in her organization are a consistent appraisal team, collaborative forums, and the program’s opportunity for planning and action.

“This is our sixth year in the program, and we've had the same lead appraiser since the beginning, and that's made a huge difference, I think,” Leaupepe said. “[O]ne of the key things that we get out of that is that they really, really understand our business and we've worked with them year on year to really get down to causes rather than trying to fix symptoms, and really understand the problems that challenge us as an organization and then focus on driving those solutions.”

Participation in the program has led to improved processes and improvements in design transfer that resulted in cost savings, improved time to market that increased revenue, and improved product performance, she explained.

VIP has “been a fantastic tool that synergizes with the way that we work,” adding that “it actually changes the perception of quality as a whole in our organization,” Leaupepe said.

Keisha Thomas, associate director for compliance and quality in OPEQ at FDA’s CDRH, said that the VIP program is a priority for the agency, and FDA is looking forward to expansion of the program and greater participation from industry.

“I can't reiterate more the value that we've seen in the brief time that this program has been a full-time program, as well as the data that came out of the pilot,” she said.

MedCon: FDA officials say VIP is ‘win-win’ for agency and industry

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