On November 14, 2022, the CPC submitted a comment letter to FDA in response to the Agency’s request for comments on its statement of work for the independent assessment of communication through product quality information requests during application reviews that will be conducted in PDUFA VII. In its comment, the CPC requests that the assessment, or another similar assessment, include information requests related to drug and/or biologic-led combination products.
On November 14, 2022, the CPC submitted a comment letter to FDA regarding the Agency’s draft guidance, “Computer Software Assurance for Production and Quality System Software”. The CPC greatly appreciates FDA’s efforts to provide this draft guidance, which helps to establish Agency expectations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. The CPC’s comments focus on applicability of the draft guidance to pharmaceutical- and drug-primary mode of action combination product production and quality system software.
On October 17, 2022, the CPC submitted a white paper to FDA detailing CPC’s position with respect to recent requests from FDA to demonstrate how companies have “validated” device user interface specifications in intended user population(s). The document lists specific concerns of CPC member companies and offers case study examples to highlight a range of experiences. As discussed further in the white paper, CPC seeks clarity on the Agency’s expectations for validation of product user interface specifications and confirmation of the context in which such validation expectations are applicable.
On July 6, 2022, the CPC submitted a comment letter to FDA regarding the Agency’s draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” CPC greatly appreciates FDA’s efforts in the draft guidance to help establish Agency expectations for the types of cybersecurity activities and evidence required to gain approval and maintain medical devices. CPC’s comments seek clarity and offer suggestions for FDA’s consideration with respect to the scope and applicability of the draft guidance to software and firmware products that are used in combination with drugs and/or are regulated as drug primary mode of action combination products.
On May 24, 2022, the CPC submitted a comment letter to FDA regarding the agency’s proposed rule regarding “Medical Devices; Quality System Regulation Amendments.” CPC greatly appreciates FDA’s efforts to harmonize good manufacturing requirements of the Quality System Regulation with the International Organization for Standardization’s consensus standard for devices, CPC’s comments highlight certain areas where CPC seeks additional clarity from FDA.
On March 22, 2022, the CPC submitted a letter to FDA regarding the agency’s draft guidance addressing “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” which will establish FDA’s expectations of the types of evidence required to support use of digital health technologies for remote data acquisition in clinical investigations. While CPC greatly appreciates FDA’s efforts to provide this draft guidance for comment, CPC’s comments highlight certain areas of concern for FDA to consider as it finalizes the guidance.
On February 1, 2022, the CPC submitted a letter to FDA regarding the agency’s recent draft guidance on the “Content of Premarket Submissions for Device Software Functions.” Overall, CPC supports further development of guidance on this topic, but would appreciate additional clarity in the final guidance regarding CPC’s comments concerning cross-Center adoption of the software review policies on software documentation and application of the guidance to NDA and IND applications.
On August 3, 2021, the CPC submitted a letter to FDA proposing that the agency adopt a risk-based policy that would relax medical device Current Good Manufacturing Practice expectations for certain low-risk medical device digital technologies deployed into Investigational New Drug Application studies. CPC detailed the applicability of its proposal, risk criteria and categories, and information required to be disclosed under the proposal. CPC emphasized that “[b]y establishing a risk-based policy allowing study sponsors to apply state-of-the-art software development and validation approaches, [FDA] will greatly improve the pace at which pharmaceutical and combination products sponsors can deploy these technologies to the benefit of patients and investigators.”
On July 19, 2021, the CPC filed a comment letter regarding FDA’s “ICH Q12: Implementation Considerations for FDA-Regulated Products” Draft Guidance. The CPC appreciates FDA’s efforts to incorporate many of the CPC’s suggestions regarding the application of ICH Q12 to combination products into FDA’s Draft Guidance. Further, CPC believes that the Draft Guidance represents a significant step forward toward enabling the combination product industry to implement ICH Q12 tools. The comments also seek additional clarity regarding the term “indirect contact” as used in the Draft Guidance.
On July 12, 2021, the CPC filed a comment letter regarding Health Canada’s “Drug-Device Combination Products (DDCPs) Draft for Consultation Issue Identification Paper.” The CPC appreciates Health Canada’s efforts to address the uniquely complex and challenging oversight required for drug-device combination products. CPC believes that global harmonization of certain standards for DDCPs across jurisdictions and streamlined approaches to minimize regulatory burdens would expedite access to innovative treatments for patients. Among other specific recommendations, CPC encourages Health Canada to issue clear guidance documents regarding these important issues.
