August 8, 2022

Stakeholders seek tweaks to FDA’s voluntary improvement program guidance

Regulatory NewsRegulatory News
| 08 July 2022 | By Jeff Craven 3044 The US Food and Drug Administration (FDA) has received comments on its draft guidance on engaging with the Voluntary Improvement Program (VIP) through the Medical Device Innovation Consortium (MDIC), and device companies want to know more about how manufacturers can benefit from participating as well as how the program fits into existing regulatory programs.

FDA’s participation in the VIP means device manufacturers can be assessed by third party appraisers that provide feedback on strengths and areas for improvement as measured by a modified version of the best practices in the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system for the medical device industry across 11 practice areas. Data can then be de-identified and shared with FDA following an appraisal. (RELATED: FDA drafts guidance on medical device voluntary improvement program, Regulatory Focus 9 May 2022)

Site visits and analyses under the VIP are not regulatory inspections or audits, the agency said in the draft guidance, and the appraisers don’t collect evidence of regulatory findings or provide regulatory observations, including a rating or certification.

“Participating manufacturing sites who demonstrate sustained capability and performance, or improvements in the appraisal results, may benefit from several opportunities that the VIP offers, following FDA’s review of the site’s appraisal,” the agency wrote in the draft guidance.

The VIP is a permanent version of the Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which FDA launched with MDIC in 2018 and was well received by a majority of participants in the pilot. (RELATED: FDA Details New Manufacturing Quality Pilot Program, Regulatory Focus 15 January 2018)

In their comments to the FDA, medical device company Medtronic proposed changing the wording in the description of the Medical Device Discovery Appraisal Program (MDDAP) to include “Governance, Implementation Infrastructure and Managing Performance and Measurement” rather than FDA’s proposed practice areas of “Estimating, Planning, and Configuration Management” because the former are three core practice areas, while the latter “may or may not be included in future appraisals.”

Medtronic also suggested FDA change how it describes the ISACA CMMI “to include that firms are encouraged to identify an appraisal scope that applies CMMI best practices to proactively identify opportunities for continuous improvement.”

“We recommend VIP continues the focus on proactive identification of opportunities for improvement. Focusing on an increasing score year over year, could disincentivize firms who, today, are encouraging transparency during appraisals, and who are continuously looking at new areas to find additional opportunities for improvement,” they wrote. “This active search for improvement opportunities could temporarily result in a dip in scores.”

The device manufacturer suggested that a copy of any de-identified, aggregate information sent to the FDA should also be sent to the participating site. Medtronic recommended FDA make it clear that the appraisers don’t retain objective evidence collected during the site visit and remove terms like “rich dataset” that might imply quantitative data are being collected.

MDIC’s VIP Expansion Working Group
The working group responsible for modifying MDIC’s VIP Reappraisal Guidelines also provided a comment to FDA and suggested changes to align with the goals of the working group. They noted the “intent of the program is to shift from a compliance mindset and towards continuous improvement.”

To that end, they suggested adding language to the draft guidance that would allow manufacturers to participate in alternate engagement activities such as focused scope appraisal, continuous improvement event, or a capability benchmark appraisal instead of a standard appraisal when appropriate.

“The intent of this objective is to maintain the requirement for all sites to regularly engage with the program while balancing a core program feature allowing flexibility for individual participant need,” they wrote.

Becton Dickinson
Medical technology company Becton Dickinson asked FDA in their comment to clarify how the program affects surveillance inspections and pre-market inspections.

“The guidance explains how participating in VIP can offer ‘risk-based inspection planning’ and potentially reduce the cadence of inspection. However, it is unclear specifically how it could potentially spare a manufacturer from a surveillance and/or premarket inspection,” they wrote. “Removing the need for surveillance and/or premarket inspections could be major incentives of participating in VIP, thus, how these inspection types are specifically impacted by VIP participation should be explained.”

W. L. Gore & Associates
Manufacturing company W. L. Gore & Associates used their comment to FDA to ask for clarity on what the agency expects in terms of “sustained capability and performance” and whether a manufacturer needs to achieve a certain maturity level to qualify for risk-based inspection planning.

Gore also requested that Office of Health Technology (OHT) officers within CDRH’s Office of Product Evaluation and Quality (OPEQ) receive training on the VIP program and features, particularly the 30-Day Change Notice submission template. They cited their experience with inconsistencies in the program.

“For example, one OHT reviewer would not accept the template during the Pilot Program because the submission included biocompatibility data. They asked that the manufacturer instead submit as a ‘traditional 30-day Notice.’ Another OHT reviewer accepted the format under the program for a similar change,” they wrote.

Boston Scientific
Medical device manufacturer Boston Scientific provided a brief comment to FDA about the VIP, asking the agency to “avoid specifying that appraisals be required annually, but instead at least leave it open to possibility that the frequency be tailored as companies/sites remain active in the program year-on-year.”

Bringing Real-world Insight for Device Governance and Evaluation (BRIDGE) Coalition
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 VIP can prove to be beneficial for some products and manufacturers,” they wrote.

However, they questioned how the program would apply to participants with multiple sites. “The program, as currently structured, works well for small entities with one 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 simultaneously cover more than one designated site,” they said.

The coalition also expressed concerns about third-party auditors. “It must be clear that this program exists outside of MDIC. Stated differently, participation in this program must be permitted outside of any specific third party. The benefits should be applicable to assessments done outside of the MDIC system,” they said. “Likewise, FDA should be open to assessments system similar to CMMI. FDA should not endorse one entity or one system for the VIP program.”

They also raised concerns about legal liability for products in the program, and the discoverability of information within the program in litigation. They suggested protections be built into the program that state submissions are not admissions of liability as well as limiting discovery of information from the program in third-party litigation. “Including similar protections in this pilot program will encourage participation and avoid disadvantaging companies that do partake in the pilot,” the group said.

The Coalition also suggested a “re-scoping” of the program to include pre-market incentives for 510(k) manufacturers in addition to pre-market approval (PMA) devices. “This program will have limited effect if it is limited to PMA devices. In many ways, this program may better fit into the Class II/special controls approach. We believe that FDA should seek public input on including Class II/special control in this program,” they wrote.

Draft guidance

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This story was originally published by RAPS.