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SummaryOn December 4, 2024 the U.S Food and Drug Administration (FDA) held a Medical Device Sterilization Town Hall: Sterilization Short Topics, Series Impact, Wrap Up, and Next Steps.During this town hall, we discussed two short topics, including the new Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices Guidance, and research and modeling on..

The FDA encourages the development of innovative, safe, and effective medical devices, including devices that incorporate Artificial Intelligence and Machine Learning (AI/ML).  The AI/ML-Enabled Medical Device List is a resource intended to identify AI/ML-enabled medical devices that are authorized for marketing in the United States (updated).  Artificial Intelligence and Machine Learning (AI/ML..

Clinical Decision Support (CDS) software are important tools in modern health care. While some CDS software has been excluded from the definition of a medical device by the 21st Century Cures Act (Cures Act), many software functions continue to meet the definition of a medical device and are the focus of the Food and Drug Administration’s (FDA) regulatory oversight. Because a wide variety of sof..

Both the FDA’s Human Factors Engineering (HFE) guidance and the global HFE standard IEC-62366 list “inherent safety by design” as the most effective method of managing use-related risks associated with medical devices. In this article, we discuss what is meant by safety by design, provide examples of products that demonstrate it and explore how it can be implemented within medical device design...

We all know the chicken or the egg causality dilemma, often introduced as “what came first, the chicken or the egg?” You could pose a similar question for risk control measures referenced in HF validation tests: What comes first, the verification of use-related risk control measures or the HF validation test?   When to Verify Risk Control Measures | Emergo by UL When to Verify Risk Control Measu..

FDA is issuing this guidance to communicate its policy regarding sterilization site changes for ethylene oxide (EtO) sterilized PMA and HDE devices in situations where those devices are affected by the potential, actual, or temporary operation reductions at sterilization facilities that may affect the availability of those sterile medical devices. FDA does not intend to object to sterilization o..

This guidance provides performance criteria for non-spinal metallic bone screws and their associated washers in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for non-spinal metallic bone screws and washers will have the option to use the performance criteria proposed in this guidanc..

This guidance document provides the FDA’s recommendations on information to support premarket submissions for orthopedic non-spinal bone plates, screws, and washers. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of orthopedic non-spinal bone plate, screw, and washer submissions.  Orthopedic Non-Spinal Bone Plates, Scr..

A companion diagnostic device can be in vitro diagnostic (IVD) device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. Below is a table of cleared or approved companion diagnostic devices (in vitro and imaging). The use of an IVD companion diagnostic device is stipulated in the instructions for use in the labeli..

SummaryThe Food and Drug Administration (FDA) is announcing a public workshop entitled “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices.” The purpose of this public workshop is for the FDA to discuss with stakeholders the expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical an..