Abstract
Manufacturers of pathology imaging devices and associated software engage regulatory affairs and clinical affairs (RACA) throughout the Total Product Life Cycle (TPLC) of regulated products. A number of manufacturers, pathologists, and end users are not familiar with how RACA involvement benefits each stage of the TPLC. RACA professionals are important contributors to product development and deployment strategies because these professionals maintain an understanding of the scientific, technical, and clinical aspects of biomedical product regulation, as well as the relevant knowledge of regulatory requirements, policies, and market trends for both local and global regulations and standards. Defining a regulatory and clinical strategy at the beginning of product design enables early evaluation of risks and provides assurance that the collected evidence supports the product's clinical claims (e.g., in a marketing application), its safe and effective use, and potential reimbursement strategies. It is recommended to involve RACA early and throughout the TPLC to assist with navigating changes in the regulatory environment and dynamic diagnostic market. Here we outline how various stakeholders can utilize RACA to navigate the nuanced landscape behind the development and use of clinical diagnostic products. Collectively, this work emphasizes the critical importance of RACA as an integral part of product development and, thereby, sustained innovation.
Highlights
Pathology is the cornerstone of patient care, providing diagnostic, prognostic, and therapypredictive information to a health care team
The safety of patients and the quality of the pathology results are critical to the practice of pathology, which is highly controlled by various regulatory bodies
It should be noted that pathology as a medical practice is not under the authority of a regulatory body
Summary
Pathology is the cornerstone of patient care, providing diagnostic, prognostic, and therapypredictive information to a health care team. RACA uses market and regulatory intelligence to work with product management and development teams to define clinical utilization, which provides clarity on the user requirements and formulation of the intended use, indications of use, and claim definitions These descriptions drive the device description, device classification, if applicable, and regulatory pathway. FDA recognized in a recently published discussion paper that AI-based SaMD algorithms, which include those for digital pathology applications, should have appropriately tailored regulatory oversight to prevent unnecessary barriers to access to innovation [22] This discussion paper proposes potential approaches that could decrease certain requirements for submissions due to device changes in the post-market, such as approval of pre-determined change-control plans that include SaMD pre-specifications and an algorithm change protocol. Given the changing nature of the regulatory landscape for innovative technologies in the post-market and varying requirements for different technologies, RACA professionals can be vital to product teams in supporting product updates
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