You’ve just realized that your medical device has a connection to the outside world and meets the definition of a cyber device per FDA guidance “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.” As the initial shock wears...
Medical device manufacturers must increasingly devote resources to identifying and managing cybersecurity risks and features of their devices. Devices that once might have been considered to have no network connectivity have been brought into regulatory focus as...
Introduction Establishing a robust compliance program is essential for any organization, particularly within the healthcare sector, where adherence to federal laws and regulations is critical. The Office of Inspector General (OIG) of the Department of Health and...
Introduction Secure design best practices (and various standards and guidance) recommend penetration testing (pentesting) be included in the secure development life cycle and conducted by a team independent of the product developers and testers. Testing should begin...
The U.S. Environmental Protection Agency (EPA) has issued a final rule aimed at limiting emissions of ethylene oxide (EtO), a carcinogenic chemical extensively used in the sterilization of medical devices, with a focus on enhancing medical device regulation. This new...
The provisional agreement on the Artificial Intelligence Act proposed by the European Parliament introduces a unified regulatory framework for AI across the EU, with significant implications for the medical device industry. This paper aims to discuss the potential...
The use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical trials and studies for FDA regulated medical products is essential for all medical product manufacturers. ...
The European Commission is considering extending the transition period for compliance with the In Vitro Diagnostic Medical Devices Regulation (IVDR) due to concerns that manufacturers might not have sufficient time to comply. The IVDR came into force in May 2022, and...
The prompt and precise registration, as well as the timely dissemination of comprehensive summary results information for relevant clinical trials on ClinicalTrials.gov, play a pivotal role in providing current research insights to various stakeholders within the...
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has revealed a roadmap for medical device regulation, aiming to prioritize patient safety and establish a new framework by 2025. As released on January 9th, 2024, the agency plans to implement priority...