by Amra Racic, senior director, global government strategy, Veeva MedTech
Every year, MassMEDIC hosts Regulatory Roundup events, designed to give regulatory, quality, and other medical device industry functions updates on the global and domestic regulatory issues facing the industry.
The agenda usually includes comprehensive updates from FDA officials, industry representatives, and other regulatory experts. Recently, Veeva MedTech was honored to interview Dr. Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDRH) at the US FDA, followed by Dr. Suzanne Schwartz, who leads the Office of Strategic Partnerships and Technology Innovation (OSPTI) at CDRH.
Here are some lessons learned from those interviews.
FDA encourages early submission of your Emergency Use Authorization (EUA) approved devices
The agency has done a great job working through the pandemic and reviewing EUAs while continuing to meet congressionally-mandated review times. However, with the Public Health Emergency declaration set to expire, the agency is encouraging everyone to file for those submissions early. In fact, many companies have already received an updated clearance / approval or have started to transition their product, allowing them to remain on the market post-EUA expiration.
Regulatory modernization and digital transformation initiatives are making headway internally at CDRH
In a recent benchmark study conducted by Veeva MedTech
of nearly 100 global medtech organizations, respondents identified digitization, the need for harmonized processes, and the use of an organization-wide, global, centralized system to enable cross-functional collaboration as key areas to drive success.
The Office of Digital Transformation (ODT) is striving towards the same goals. They now sit within the OSPTI providing leadership in information technology, data, and cybersecurity. While the year 2022 was spent reestablishing the new office and objectives, we are anticipating that 2023 will bring collaboration and strategic alignment across the industry ecosystem. That will help the agency meet their ODT strategic priorities, including migration and use of the cloud, strengthening the IT infrastructure, and enhancing security measures when addressing cybersecurity.
Omnibus Act will have significant implications for how security for medical devices is both regulated and enforced
On Dec. 29, 2022, President Biden signed into law a significant spending bill with major implications for medical device security. Manufacturers are now required to include evidence of security controls and testing in addition to documented plans on how to maintain a device’s security through various updates.
Within the Omnibus Act, the concept of predetermined change control plans for adaptive machine-learning-based devices has also been approved. For Software as a Medical Device (SaMD), this could be very helpful for manufacturers to align on planned changes and ease the burden of future modifications and submissions. A draft Guidance is expected in the upcoming months that will clarify how medical device manufacturers can best prepare for this implementation.
CDRH is moving towards more flexibility in workspace
As an employer of thousands of workers, work-life balance is important to CDRH. During the pandemic, most of these employees conducted all work remotely. To remain competitive in the job market, the agency has needed to adjust its requirements surrounding remote and office-based work, especially when seeking to attract and retain subject matter experts. They have worked to come up with recruitment packages and employee guidelines that enable the workers to be productive remotely. A number of individuals within OSTPI, both within the digital health center of excellence on the West Coast, as well as on the supply chain resilience team, now work remotely. These updated policies have allowed the FDA to be more competitive in the market for top talent.