Stakeholders Seek Changes to FDA Voluntary Improvement Program Guidelines
| July 08, 2022 | By
The U.S. Food and Drug Administration (FDA) has received feedback on its draft guidance on Voluntary Improvement Program (VIP) participation through the Medical Device Innovation Consortium (MDIC), and device manufacturers devices want to learn more about how manufacturers can benefit from participation. as well as how the program fits into existing regulatory programs.
FDA’s participation in VIP means that device manufacturers can be evaluated by third-party evaluators who provide feedback on strengths and areas for improvement, as measured by a modified version of the Information Systems Best Practices Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) for the medical device industry in 11 practice areas. The data can then be anonymized and shared with the FDA after an evaluation. (RELATED: FDA Drafts Medical Device Voluntary Improvement Program Guidance, Regulatory guidance May 9, 2022)
VIP site visits and analyzes are not regulatory inspections or audits, the agency said in the draft guidelines, and evaluators do not gather evidence of regulatory findings or provide observations. regulations, including a rating or certification.
“Participating manufacturing sites that demonstrate sustained capability and performance, or improvements in assessment results, may benefit from several VIP opportunities, following FDA review of the assessment. of the site,” the agency wrote in the draft guidelines.
The VIP is a permanent version of the Case for Quality Voluntary Medical Device Manufacturing and Product Quality pilot program, which the FDA launched with MDIC in 2018 and which was well received by the majority of pilot participants. (RELATED: FDA Details New Manufacturing Quality Pilot Program, Regulatory guidance January 15, 2018)
In its comments to the FDA, medical device company Medtronic proposed changing the wording of the Medical Device Discovery Evaluation Program (MDDAP) description to include “Governance, Implementation Infrastructure, and Performance Management and Measurement” rather than the FDA’s proposed practice areas: “Estimating, Planning, and Configuration Management”, as the former are three core practice areas, while the latter “may or may not be included in future assessments. “.
Medtronic also suggested the FDA change how it describes ISACA CMMI “to include that companies are encouraged to identify an assessment scope that applies CMMI best practices to proactively identify opportunities for continuous improvement. “.
“We recommend that VIP continue to focus on proactively identifying opportunities for improvement. Focusing on an increasing score from year to year could discourage companies that today encourage transparency in ratings and are constantly looking for new areas to find new opportunities for improvement,” they wrote. “This active search for improvement opportunities could temporarily cause scores to drop.”
The device manufacturer suggested that a copy of any anonymized aggregate information sent to the FDA also be sent to the participating site. Medtronic recommended that the FDA clearly state that evaluators do not retain objective evidence collected during the site visit and remove terms such as “rich dataset” that could imply that quantitative data is being collected.
MDIC VIP Expansion Task Force
The Task Force to Amend the MDIC VIP Re-evaluation Guidelines also provided feedback to the FDA and suggested changes to align with the Task Force’s objectives. They noted that “the intention of the program is to move from a mindset of compliance to continuous improvement.”
To that end, they suggested adding language to the draft guidelines that would allow manufacturers to participate in other engagement activities such as a targeted scoping assessment, continuous improvement event, or performance assessment. capacity benchmark instead of a standard assessment, if applicable.
“The intent of this goal is to maintain the requirement for all sites to regularly engage in the program while balancing a core feature of the program allowing flexibility for individual participant needs,” they wrote.
Medical technology company Becton Dickinson asked the FDA in its comment to clarify how the program affects surveillance inspections and premarket inspections.
“The guidelines explain how VIP participation can offer “risk-based inspection planning” and potentially reduce inspection tempo. However, it is unclear precisely how this could potentially spare a manufacturer from surveillance and/or premarket inspection,” they wrote. “Removing the need for surveillance and/or pre-market inspections could be a major incentive to participate in VIP, therefore, how these types of inspections are specifically impacted by VIP participation should be explained. “
WL Gore & Associates
Manufacturing company WL Gore & Associates used its comment to the FDA to seek clarification on what the agency expects in terms of “sustainable capability and performance” and whether a manufacturer must reach a certain level of maturity to qualify. for risk-based inspection planning.
Gore also requested that officers in the Office of Health Technologies (OHT) within CDRH’s Office of Product Evaluation and Quality (OPEQ) receive training on the VIP program and features, specifically the 30 day change notice submission template. They cited their experience with inconsistencies in the program.
“For example, an OHT reviewer would not accept the model during the pilot program because the submission included biocompatibility data. They asked the manufacturer to submit a “traditional 30-day notice” instead. Another OHT reviewer accepted the format as part of the program for a similar change,” they wrote.
Medical device maker Boston Scientific provided a brief comment to the FDA about the VIP, asking the agency “to avoid specifying that reviews are required every year, but at least leave room for the frequency to be adapted as companies/sites remain active in the program from year to year.
BRIDGE Coalition (Bringing Real-world Insight for Device Governance and Evaluation)
The BRIDGE Coalition emphasized in their comment that the permanent program should be as flexible and responsive as the pilot program. “We support quality measures and believe that VIP may prove beneficial for certain products and manufacturers,” they wrote.
However, they asked how the program would apply to participants with multiple sites. “The program, as currently structured, works well for small entities with a single facility, or large manufacturers who only designate one or two sites for certification. The biggest gain for large manufacturers with multiple sites would be an enterprise program that could cover more than one designated site simultaneously,” they said.
The coalition also expressed concerns about third-party auditors. “It should be clear that this program exists outside the MDIC. In other words, participation in this program must be authorized apart from any specific third party. The benefits should be applicable to assessments performed outside of the MDIC system,” they said. “Similarly, the FDA should be open to an evaluation system similar to the CMMI. The FDA should not approve any entity or system for the VIP program.
They also raised concerns about the legal liability of the program’s products and the possibility of discovering information within the program in the event of a dispute. They suggested that safeguards be built into the program so that state submissions are not admissions of liability and that they limit discovery of program information in disputes with third parties. “Including similar protections in this pilot program will encourage participation and avoid disadvantaging companies that participate in the pilot,” the group said.
The Coalition also suggested a “redesign” of the program to include premarket incentives for 510(k) manufacturers in addition to premarket approval (PMA) devices. “This program will have limited effect if limited to PMA devices. In many ways, this program could fit better into the Class II/Special Controls approach. We believe the FDA should seek the advice of the public about the inclusion of Class II/Special Control in this program,” they wrote.
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