Welcome to the December issue of RF Quarterly in which global regulatory experts write about the role of artificial intelligence (AI) in regulatory practice, with a focus on global change management of AI-based medical devices, AI in regulatory intelligence knowledge management, synthetic data and the innovation, assessment, and regulation of AI medical devices, and digital transformation.   We thank the authors for their generosity in sharing their knowledge and exper...

A newly finalized guidance from the US Food and Drug Administration (FDA) helps manufacturers understand how to use near-infrared (NIR)-based analyses in evaluating drug attributes.   The guidance finalizes a draft issued in 2015, updating it to better reflect how NIR has been used in the years since the draft was issued, and to incorporate some advances in NIR technology. Considerations for managing NIR over the product life cycle were also added to the finalized guid...

In the latest negotiation session for the upcoming Medical Device User Fee Amendments (MDUFA V) program, the US Food and Drug Administration (FDA) and industry groups diverged over the agency’s ambitions for the next five-year program and the industry’s desire to lock-in gains from past programs.   TPLC Advisory Program   During the previous meeting on 7 April, FDA presented its vision for a Total Product Lifecycle (TPLC) Advisory Program (TAP) to a skeptical indus...

Minutes from the latest round of negotiations between the US Food and Drug Administration (FDA) and industry around the next iteration of the Medical Device User Fee Amendments (MDUFA V) have been released to the public and highlight how stakeholders are approaching the talks with different goals in mind.   Negotiations for MDUFA V began this year after months of delays due to the COVID-19 pandemic. Last year, a public kick-off meeting was pushed from April 2020 to Oct...

The work at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on advanced continuous learning for regulatory processes is informing agency-wide efforts. FDA principal deputy commissioner Amy Abernethy touched on how CDRH projects and other initiatives leverage the continuous learning approach during a Wednesday keynote discussion at AcademyHealth’s Health Datapalooza 2019 in Washington, D.C. In an interview with Focus , Ab...

Responding to a letter from Sen. Mark Warner (D-VA) that called for a collaborative effort to advance cybersecurity in health care, medical device industry group AdvaMed sought to ease concerns about the impact of cyber attacks with updates on industry and regulators’ moves in line with its five principles. The industry trade association’s board of directors adopted the set of five medical device cybersecurity principles in 2017 to drive best practices across its member...

The industry group that set forth the new work item for a globally harmonized approach to medical device cybersecurity, which is currently under development, released a new white paper that provides an overview of best cybersecurity practices in medical technology manufacturing. The new white paper is intended to increase a manufacturer’s level of cybersecurity sophistication in manufacturing and engineering processes by following seven principles. These include segment...

The US Food and Drug Administration (FDA) on Monday published final guidance on the FD&C Act’s least burdensome provisions for the regulation of medical devices, highlighting recent initiatives via newly added themes. The 24-page document, which finalizes a draft from December 2017, is intended to reflect guiding principles that require “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient...

Under a US Food and Drug Administration (FDA) contract, a new rubric developed by the Mitre Corporation is the first-of-its-kind to be specifically tailored to medical devices, and is set to take the form of a medical device development tool (MDDT) to ensure consistency in scoring cybersecurity risks. The common vulnerability scoring system (CVSS) open standard for assessing software vulnerability severity has seen widespread use on an international scale since its 2005...

The Healthcare and Public Health Sector Coordinating Council (HSCC) released a new medical device and health IT joint security plan (JSP) Monday to serve as a reference guide for strengthened cybersecurity. Industry-driven public-private partnership HSCC developed the new JSP in response to 2017 recommendations from the Health Care Industry Cybersecurity Task Force. It specifically addresses the second imperative identified by the task force—increase the security and re...