Impact of Medical Device Supply Chain Vulnerabilities on Public Health
The U.S. Food and Drug Administration (FDA) is focused on preventing and mitigating medical device shortages, which pose significant risks to patient care, particularly for vulnerable populations like neonatal and pediatric patients. From premature infants in neonatal intensive care units to children with chronic illnesses requiring long-term medical interventions, the need for appropriately sized, high-quality […]
Case Study: Navigating Regulatory Challenges to Achieve FDA Clearance
Background and Challenge: A medical device manufacturer sought FDA clearance for its innovative lidocaine delivery device designed to deliver aerosolized lidocaine to the upper airway to facilitate office-based procedures. The company initially engaged with a different consulting company to prepare and submit the 510(k) application. However, after receiving an Additional Information Needed (AIN) letter from […]
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FDA recently issued a draft guidance document on “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” .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On January 7, 2025, the FDA issued a draft guidance document on “Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies”. This draft guidance emphasizes the importance of inclusive and representative research to ensure devices are safe and effective for diverse populations.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 […]
Navigating the FDA QMSR Transition: Expert Guidance for a Seamless Journey
Are you ready for the FDA’s Quality Management System Regulation (QMSR) transition? The FDA’s new QMSR is set to become effective in February 2026. As a complex regulatory change, it requires careful planning and execution to ensure compliance. Don’t wait — get started now! Why Choose AlvaMed? Our team of experienced quality and regulatory experts […]
Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices
The FDA has issued a final guidance titled “Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices.” This guidance outlines the agency’s policy regarding sterilization site changes for Class III medical devices sterilized using ethylene oxide (EtO). It is intended to address potential or actual disruptions at sterilization facilities that may […]
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 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 […]
US Regulation of Ingestible Medical Devices
Ingestible medical devices are at the forefront of innovation in healthcare, offering unique solutions for monitoring patient health and delivering therapies. These devices, which can be swallowed and often operate within the gastrointestinal tract, range from capsule endoscopes to drug delivery systems. As their use expands, understanding the regulatory framework governing these technologies in the […]
