Congratulations to Jithesh Veetil, PhD, awarded The CDRH Regulatory Science Excellence Award for for the External Evidence Methods (EEM) Framework Project. MDIC EEM Framework is a document intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. Informed by a number of public forums and a survey of medical device manufacturers, the document catalogs different sources of external data and some of the traditional and novel statistical methods (Frequentist and Bayesian) applicable to the design and analysis of a clinical study in which external data play a role. Join Dr. Veetil at the JSM 2022 Conference for “Advancing Regulatory Science for Medical Devices and Medical Software Through Collaboration”, August 10, 2022 at 10:30 AM.
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| 08 July 2022 | By Jeff Craven 3044 The US Food and Drug Administration (FDA) has received comments on its draft guidance on engaging with the Voluntary Improvement Program (VIP) through the Medical Device Innovation Consortium (MDIC), and device companies want to know more about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Site visits and analyses under the VIP are not regulatory inspections or audits, the agency said in the draft guidance, and the appraisers don’t collect evidence of regulatory findings or provide regulatory observations, including a rating or certification.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several opportunities that the VIP offers, following FDA’s review of the site’s appraisal,” the agency wrote in the draft guidance.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.
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.
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.
© 2022 Regulatory Affairs Professionals Society.
MDIC’s Patient Advisory Group (PAG) developed this survey to collect your feedback regarding the processes and mechanisms you use to engage with patients throughout the total product lifecycle (TPLC).
NOTE: The focus of the survey is on patient engagement and the use of patient personas in the product development process. We are not asking for responses related to patient support initiatives regarding adverse events or general questions.
The Patient Engagement Survey aims to understand current patient engagement and how patient input is considered in the pre-market and post-market phases of medical devices.
The survey was created in collaboration with SPI’s Patient Preference Information working groups. The PAG and Patient Preference Information (PPI) teams will analyze survey results to understand the needs and challenges of MDIC member organizations regarding patient engagement. The results will also be used to develop the Patient Advisory Group initiatives and provide input for landscaping and understanding current patient engagement opportunities along the total product lifecycle.
To start the survey, click here.
Registration is open for the 2022 MDIC Annual Public Forum to be held in Washington, DC, on Tuesday September 13 – our first in-person APF since 2019! Join us for General Sessions on Digital Health, Health Economics & Patient Value, and NESTcc, as well as concurrent sessions across a wide range of topics and Fireside Chats with representatives from FDA and CMS. Be a part of the event that gathers industry experts, innovators, and regulators and addresses the latest issues facing the medical device community.
The Master Clinical Trial Agreement (MCTA) working group and Informed Consent and Institutional Review Board (ICF) working group within the Early Feasibility Studies (EFS) program have completed updates to two key EFS resources.
Building on the 2017 EFS project success, in 2018 the EFS Contracts working group set out, for the first time, to (A) develop an EFS-specific Master Clinical Trial Agreement (MCTA), and (B) make that EFS MCTA publicly available on the MDIC website for both medical technology and care provider EFS participants. With engagement of diverse stakeholders including industry, care provider organizations, and regulators, the goal of releasing this MCTA is to facilitate efficiencies in the EFS contracting process by developing an EFS MCTA providing (1) a starting point for contract negotiations with a priori agreement of 90% or greater, and (2) allow both parties to focus remaining legal resources on the remaining 10% (or less) of the EFS MCTA requiring negotiation. The Early Feasibility Study Master Clinical Trial Agreement can be found here.
A template of a patient Informed Consent Form (ICF) for adult patients considering participation in a study being conducted under an IDE through the FDA’s EFS Program was developed as part of the 2016 Blueprint for Early Feasibility Study Success. Updated for 2022, the ICF throughly outlines how those conducting studies can explain the process of participating in a study, the benefits of contributing to research as participant of early feasibility studies, the risks associated with participation and the patients rights to potential participants. Click here to see the full template.
The Medical Device Innovation Consortium (MDIC), today announced the publication of the MDIC External Evidence Methods (EEM) Framework. This framework, developed by subject matter experts from industry, academia, and the U.S. Food and Drug Administration (FDA), is a document intended to help stakeholders navigate their way through the process of leveraging external data by harnessing the power of statistics. The 21st Century Cures Act, as well as the learnings from the COVID-19 public health emergency, underscored the need to expand the role of relevant external data in the total product lifecycle of medical devices.
To read the full release click here.
The U.S. Food and Drug Administration (FDA) today announced that the National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), has achieved recognition as one of the first collaborative communities with participation by the FDA’s Center for Devices and Radiological Health (CDRH).
CDRH identified participation in collaborative communities as a strategic priority for 2018 to 2020. The purpose of a collaborative community is to bring together medical device stakeholders in a continuing forum of private- and public-sector members, including the FDA, to achieve common outcomes, solve shared challenges, and leverage collective opportunities. Ultimately, collaborative communities seek to contribute to the improvement of areas affecting U.S. patients and healthcare.
The mission of NESTcc is to accelerate the development and translation of new and safe health technologies, leveraging real-world evidence (RWE), and innovative research. In support of this mission, NESTcc works with stakeholders across the medical device ecosystem to catalyze the timely, reliable, and cost-effective development of RWE to enhance regulatory and clinical decision-making.
NESTcc aimed to become a collaborative community as part of its 2019 strategic and operating plan, and amended its charter to align with the FDA’s Collaborative Communities Toolkit. Members of the NESTcc Governing Committee represent their own perspectives, as well as those of their larger stakeholder communities, with the intention of ensuring diverse and distributed leadership of NESTcc among patients, payers, the medical device industry, health care professionals and regulatory bodies.
In addition to the National Evaluation System for health Technology Coordinating Center (NESTcc) Collaborative Community, FDA announced that CDRH will also participate as a member of the Ophthalmic Imaging Collaborative Community.
For more information, see the FDA announcement.
MDIC, FDA and Digital Pathology Association (DPA) are working to prioritize the areas of Digital Pathology and AI where MDIC can bring industry, users, government, insurance companies, and patients together to collaboratively work on several new projects. This alliance aims to work on:
- Temporary framework to synergize and tackle larger scale projects
- Harmonizing & standardizing a reference set to be used in end to end workflow by:
- Creating tools and datasets
- Progressing and enabling market access
- Creating clarity on regulatory pathways via mock submissions
- Harmonizing efforts between various stakeholders to optimize interoperability, integration and implementation
A successful initial meeting was held at the FDA on July 18, 2019. Over 50 attendees from various entities were in attendance. Attendees shared an interest to encourage innovation and commercialization by developing evaluation tools, methods and standards, and clarifying regulatory pathways in digital pathology and specifically in the AI space were present. A temporary alliance has been established between the different participating entities with the intent to grow the alliance to incorporate additional stakeholders. We encourage your participation as we develop project aims and deliverables. If you’re interested in this new effort, please contact MDIC program directors Jithesh Veetil or Carolyn Hiller for more information on how to get involved.
MDIC is seeking public comments on its Best Practices for Communicating Benefit, Risk and Uncertainty white paper in support of the Framework for Patient Input in Medical Device Clinical Trials that is set to be complete next year.
MDIC’s Science of Patient Input Steering Committee has worked to understand the best methods to assess patient preferences for benefit and risk in new technologies. As the Committee worked to identify the best methods for assessing patient preferences, they realized there was also a significant need to understand the best evidence-based practices to effectively communicate the benefits, risks and uncertainty of medical technologies to patients and providers. This white paper aims to be a useful resource for all of MDIC stakeholders, including researchers, regulators, clinicians, and patients.
The Framework for Patient Input in Medical Device Clinical Trials will advance methods to integrate patient input into the design of clinical trials, advance a transformative method for integrating patient preferences into the statistical design of clinical trials, and synthesize practical considerations for reducing the patient burden of participation in clinical trials. It will develop and emphasize evidence-based tools for engaging with patients in the design of clinical trials. Additional resources will be released this fall for public comment, all in support of this larger framework.
View the white paper, here.
The public comment period is open from August 12 – September 13, 2019.