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[US, FDA] FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices

Today, the U.S. Food and Drug Administration is alerting patients of a safety concern regarding diabetes devices, such as continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems, that rely on a smartphone to deliver critical safety alerts. Users of these smartphone-compatible diabetes devices can configure alert settings, such as which alerts to receive, how often ..

Why pilot tests are essential for usability studiesDeveloping a methodology for usability studies can involve uncertainty and introduce questions such as “How long should the test session last?,” “How can I improve my setup?” or “Is this prompt clear enough?” Running pilot test sessions prior to formal testing can help you find answers to these questions and increase the data quality of your upc..

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..

It has caused years and years of regulatory uncertainty: Which EU law regulates ethylene oxide (EtO) used for sterilization of medical devices? At least for medical device and IVD manufacturers, this should be clear by now, with the publication of “MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the sterilization of medical  devices”.  What the MDCG document regulating steril..

1. Introduction The regulatory status of ethylene oxide (EtO) for the sterilisation of single-use medical devices during the manufacturing process has been discussed in relation to the Review Programme under Regulation (EU) 528/2012 on biocidal products (BPR). Ethylene oxide (EtO) is used to sterilise a wide range of medical products, such as medical devices, in vitro diagnostic medical devices ..

While it was a whirlwind of less than 25 minutes for five lofty learning objectives on global regulatory strategy, we felt all the topics were seminal. A synopsis of one part of our presentation follows. The importance of a well-defined intended purpose and indications for useAs we continue to observe issues related to the intended purpose/use and indications for use, we emphasized the importanc..

Gamification is the planned use of game-like elements (such as virtual reality games, indoor games, interactive quizzes, progress tracking and rewarding with scores, badges and motivation feedback) to motivate individuals to engage in non-game activities. When considering the healthcare environment (for treatment, medication tracking and mental or physical wellbeing), including gamification can ..

On September 18, Robert Reid, Ph.D. Deputy Director, Innovative Devices at the Medicines and Healthcare products Regulatory Agency (MHRA), updated the RAPS audience on the current status of the UK legislation. To our knowledge, this is one of the most recent updates from the MHRA. The first half of 2024In January 2024, the MHRA shared a roadmap for 2024-2025. The roadmap proposed regulatory refo..

Background on NOM-240-SSA1-2024The regulator in Mexico, COFEPRIS, released on July 24, 2024, a new draft for the NOM for Medical Device Technovigilance, PROY-NOM-240-SSA1-2024. This update follows a trend of recent revisions over Mexican Standards (Emergo reported on PROY-NOM-137-SSA1-2024, Medical Device Labeling). The current version of NOM-240 was published in 2012, so an update was overdue t..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Japan Regulatory Requirements - Medical Device Software▶ 일시: 2024년 08월 08일 CST 9시 (한국시간: 08월 08일 23시) As the global market for medical device software (SaMD) expands, navigating the regulatory landscape becomes increasingly critical for manufacturers. While many regions share similar regulatory approaches, Japan presents unique challenges and opportunities. Our u..