Regulatory & Compliance Perspectives

41. FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection 7/25/2024

    The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.

42. How Early Talks With The FDA Can Pave Your DTx Approval Pathway 7/22/2024

    Consultant Acacia Parks discusses when and how DTx developers should work with the FDA to improve their overall development and clinical trial processes.

43. Making Good Decisions When FDA Investigators Come Knocking 7/18/2024

    Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.

44. Bacterial Endotoxin Testing, Part 1: Overview 7/16/2024

    All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.

45. Data-Driven Trends In Predetermined Change Control Plans 7/12/2024

    The FDA introduced the concept of the predetermined change control plan to address the dynamic nature of medical devices, particularly those using software and AI. Bridging Consulting conducted a data-driven study and shares the key findings.

46. Understanding The Potential Of AI Med Devices Amid Regulatory Challenges 7/9/2024

    As AI medical devices continue to evolve, collaborating with regulatory experts and embracing multidisciplinary approaches are crucial for navigating challenges and ensuring regulatory compliance.

47. Adaptive AI-Driven Medical Devices In The US: Regulatory Guidelines 7/8/2024

    This article delves in what is considered an adaptive AI-driven medical device and the current FDA regulatory considerations for them.

48. Is Mexico A Prime Location For Medical Device Clinical Trials? 6/27/2024

    Mexico, one of Latin America's largest economies and most populous countries, is emerging as a prime destination for medical device clinical trials and other advanced medical technologies.

49. Long Live Design Controls, Part II: A Systems Engineering Perspective In The QMSR Paradigm 6/6/2024

    The waterfall model and the V-model are commonly employed in medical device development. In our new era of the Quality Management System Regulation (QMSR), risk management can be integrated with the design control process.

50. Balancing Sustainability With Patient Safety In Medical Device Design 6/3/2024

    There is increasing pressure on manufacturers to make devices that combine safety and effectiveness with sustainability, particularly with regard to EU regulations and directives.