Shaping the Future of Medical Devices: FDA's CDRH Strategic Agenda for 2023 and Beyond

The COVID-19 pandemic was an eye-opener. Despite all the advancements in science and technology, the world came to a standstill due to this virulent virus that spread rapidly, causing death and disease and compelling lockdowns to curtail its efforts. It also revealed the need to be ever-prepared to face such unforeseen calamities and ensure the safety of our public spaces, including the workplace.

The FDA, as part of its commitment to keeping employees safe through stringent health and safety measures, is building a forward-looking Center for Devices and Radiological Health (CDRH) that leverages technological innovations to manage and combat unforeseen health challenges at the national level, all while remaining dedicated to engaging with and serving the American public.

The three Strategic Priorities for 2022-2025 represent a seamless progression building upon the accomplishments of the FDA’s previous Strategic Priorities from 2018-2020, with further continuity into 2021. These priorities are aimed at:

• Promoting a Modern and Diverse Workforce: This further strengthens the already outstanding workforce by cultivating a proactive, flexible, and collaborative environment where employees are fully engaged. Businesses can embrace digital collaboration, technology, and diverse perspectives to leverage the organization’s wealth of experience, skills, and knowledge. This priority ensures that organizations are well-equipped to face future disruptions while maintaining a healthy work-life balance, encouraging creativity, and fostering a culture of trust and empowerment. However, to support a modern and diverse workforce, it is imperative to build an agile and resilient organization that can swiftly adapt to changes without disrupting the Center's operations or compromising the well-being of the employees.
• Enhancing Organizational Agility and Resilience: This focuses on the ability to quickly and effectively adapt or revamp the business processes, approaches, and policies to stay ahead of future demands. This initiative aims to foster an environment that promotes continuous learning and development, providing ample support to your employees. You will prioritize agile improvements and redesign of processes, policies, and programs while also building the necessary capacity within the organization. These efforts are essential in creating and supporting the vision of a Modern and Diverse Workforce you aspire to become.
• Advance Health Equity: This is a top priority that underscores CDRH's commitment to developing knowledge and safe, effective technologies that cater to the requirements of all patients and consumers. Many organizations believe that technologies, especially digital health solutions, can play a pivotal role in bridging healthcare disparities and enhancing overall well-being for everyone. These technologies must be thoughtfully designed and targeted to address the unique needs of diverse populations.

FDA’s A And B Guidance Lists

CDRH has outlined its prioritized guidance documents to be published in FY2023. These guidance topics encompass both final and draft versions.

A-List:

Final Guidance Topics:

• Remanufacturing of Medical Devices
• Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
• Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
• Content of Premarket Submissions for Device Software Functions
• Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
• Revised Breakthrough Devices Program

Draft Guidance Topics:

• Voluntary Malfunction Summary Reporting (VMSR) Medical Device Reporting (MDR) for Manufacturers
• Clinical Considerations for Medical Device Premarket Submissions Targeting Opioid Use Disorder
• Select Updates for Guidance for the Breakthrough Devices Program
• Electronic Submission Template for De Novo Request Submissions

B-List:

Final Guidance Topics:

• Peroxide-Based Contact Lens Care Products – Patient Labeling Recommendations

Draft Guidance Topics:

• Chemical Analysis for Biocompatibility Assessment of Medical Devices
• Marketing Submission Recommendations for a Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
• Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies (revision of Evaluation of Sex-Specific Data in Medical Device Clinical Studies)
• The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
• Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
• Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

These guidance documents provide important information for manufacturers and stakeholders in the medical device industry to ensure the safety and effectiveness of medical devices and streamline the regulatory processes.

Introducing the Digital Transformation Initiative of CDRH

The Digital Transformation Initiative of CDRH aims to enhance the user experience for both internal and external FDA customers. This initiative focuses on improving data acceptance, storage, analysis, and distribution capabilities while modernizing and digitizing CDRH's programs and operations. Currently, CDRH relies on over 30 outdated and complex data systems for premarket review, leading to inefficiencies and high costs for upgrades and maintenance. The organization invested in an integrated knowledge management system with secure cloud-based data storage to address these challenges, facilitating better data delivery to staff and external stakeholders. This initiative represents a long-term capital improvement effort to drive positive changes in CDRH's digital infrastructure.

Next steps:

Technological advancements and the FDA's push for improved post-market reporting and safety monitoring will impact businesses in the medical device industry. To meet the changing scenario, companies must embrace digital transformation, prioritize safety, stay informed about regulations, foster innovation, and collaborate with stakeholders. Adapting to these changes will be vital for their success and public health improvement and enable compliance with the Digital Transformation Initiative requirement by providing advanced reporting and analytics, streamlined complaint management, quality control solutions, EHR integration, cybersecurity, and data privacy measures. These offerings support better post-market reporting, monitoring, and overall patient safety while facilitating the adoption of innovative and safer medical products.

Recently, ComplianceQuest presented a webinar on “Understanding the FDA’s Strategic Priorities for CDRH for 2023 and Beyond”. This webinar talks about CDRH proposed guidelines for the fiscal year 2023, CDRH Office of Digital Transformation Plan and the difference between draft guidance and final guidance.