Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
FDA recently issued a draft guidance document on “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” . The FDA guidance provides recommendations for sponsors, clinical investigators, and Institutional Review Boards (IRBs) on defining, identifying, and reporting protocol deviations in clinical investigations. While FDA regulations do not explicitly define protocol deviations or classify […]
Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies
On January 7, 2025, the FDA issued a draft guidance document on “Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies”. This draft guidance emphasizes the importance of inclusive and representative research to ensure devices are safe and effective for diverse populations. This guidance builds on the previous “Evaluation of Sex-Specific Data in […]
FDA’s Quality Management Maturity Program
In an era where medical devices and pharmaceuticals are becoming increasingly complex, ensuring their safety and efficacy is paramount. The FDA’s Quality Management Maturity (QMM) Program represents a significant step forward in achieving this goal. By focusing on the quality management systems of manufacturers, the QMM Program aims to enhance the overall safety and effectiveness […]
European Commission’s Guidance for Joint Clinical Assessments
In an effort to streamline and enhance the evaluation of health technologies across Europe, the European Commission has released a comprehensive guide focused on the validity of studies for joint clinical assessments (JCAs). This initiative, rolled out under the EU Health Technology Assessment Regulation (HTAR), represents a significant step toward harmonizing the assessment of new […]
The Canadian Artificial Intelligence and Data Act
In an era where artificial intelligence (AI) is rapidly transforming industries and societal norms, Canada has taken a significant step forward by introducing the Artificial Intelligence and Data Act (AIDA). This landmark legislation aims to establish a robust framework for the development and use of AI technologies while ensuring ethical standards, transparency, and accountability. What […]
Sage Product Development, Inc. & AlvaMed, Inc. Combining Expertise for Comprehensive Medical Device Solutions
Sage Product Development, a leader in medical device product development, announces a strategic partnership with AlvaMed, a renowned provider of quality, regulatory, and clinical services. This collaboration marks a significant step forward for early-stage medical device companies, uniting both organizations’ expertise to offer comprehensive support throughout the process. With specialized insights from Sage and AlvaMed, […]
IVDR Class D Diagnostics Transitional Provisions Q&A Updates
To support the diagnostics sector, the Medical Device Coordination Group (MDCG) has released an updated Q&A document regarding the transitional provisions for the certification of Class D diagnostics. This update is crucial for manufacturers and stakeholders navigating the complexities of regulatory compliance under the In Vitro Diagnostic Medical Devices Regulation (IVDR). Class D diagnostics are […]
The Global Regulatory Landscape for AI/ML-Enabled Medical Devices
As artificial intelligence (AI) and machine learning (ML) technologies rapidly evolve, their integration into medical devices is transforming healthcare. From diagnostic tools to treatment algorithms, AI/ML-enabled devices offer significant benefits but also pose unique regulatory challenges. Technology in medical device applications is shifting and digital health is becoming more a part of every-day healthcare, through […]
The Impact of Augmented Reality and Virtual Reality on Medical Devices
In recent years, Augmented Reality (AR) and Virtual Reality (VR) have emerged as transformative technologies across various sectors, and healthcare is no exception. Their integration into medical devices is revolutionizing everything from surgical procedures to patient education. It’s important to understand how AR and VR are impacting medical devices, enhancing healthcare delivery, and improving patient […]
The Status of Use-Related Risk Analysis
Recently, a coalition of industry groups has made a strong call for revisions to the U.S. Food and Drug Administration’s (FDA) guidance on use-related risk analyses (URRA). This plea for change underscores growing concerns about the practical implications of the current guidelines and their impact on the development and approval of medical devices. The Current […]
