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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 ..

The United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) recently released its 2024 Annual Report (link currently broken, but we will post once available from CDRH) highlighting some of its achievements over the past year. This is a summary of the main topics.The US FDA CDRH in 2024The CDRH is responsible for regulating medical devices in the U.S. It..

This month, the U.S. Food and Drug Administration (FDA), finalized guidance requiring manufacturers to notify them of discontinuations or meaningful interruptions in manufacturing for many devices during or in advance of a public health emergency (PHE). This relatively new authority was established through the 2020 CARES Act and amended by the 2023 Omnibus Consolidated Appropriations Act, alteri..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Determining when to utilize the pre-submissions Q-submission (Pre-Sub) Process▶ 일시: 2025년 02월 12일 CST 9시 (한국시간: 02월 13일 00시) In many cases, a manufacturer must submit a marketing submission (such as a 510(k)) to the U.S. Food and Drug Administration (FDA) and have it authorized before they can start selling that device in the U.S. But what if a manufacturer has q..

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..

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..