Category: Device
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HHS STI Plan
The U.S. Department of Health and Human Services (HHS) Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025. Washington, DC: U.S. Department of Health and Human Services; 2020 cites the need for innovative solutions and approaches to address the ongoing and emerging challenges to Sexually Transmitted Infections (STI) prevention and control, including expanding…
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CDISC SDTM Mapping
Introduction Timely, clear and actionable data insights allow important clinical decisions to be made in real time. And earlier insights mean life-changing or life-enhancing medicines can be brought to those in need faster. When it comes to clinical trials, data is everything. Data analytics answers questions like Is a drug working? Do side effects exist?…
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SR and NSR Considerations
Investigational IVD research sponsors (and sponsor-investigators) need to make SR/NSR device determinations and provide study-specific justification for their assessment to institutional review boards (IRBs). Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) requirements (21 CFR 812). Unless the study meets certain IDE exemption…
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Snapshots of Approved High Risk Devices
In mid-October 2024, FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot program to provide consumers and health care professionals with crucial information about clinical trials that supported the FDA’s approval of new medical devices. This program is modeled after the Center for Drug Evaluation and Research (CDER) drug trials snapshots program. The medical device pilot…
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ISO 13485 Brief
ISO 13485 is the internationally recognized quality management benchmark for medical device manufacturers. Getting ISO 13485 certified conveys trust of by regulators, stakeholders, and customers while clearing the path market. ISO 13485:2016 offers benefits: ISO 13485 is an internationally agreed upon set of standard quality management system (QMS) requirements for companies involved in the design, production, installation,…
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IVDR
The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 has been in effect since May 26, 2022. The IVDR replaced the In Vitro Diagnostic Medical Devices Directive (IVDD). The IVDR establishes a new classification system for diagnostics and requires a conformity assessment from a Notified Body. It also requires manufacturers to report serious incidents and trends in non-serious…
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Regulatory Intelligence
Regulatory intelligence (RI) is the process of collecting, analyzing, and interpreting information about regulatory requirements, changes, and trends affecting a specific industry or organization. The US Food and Drug Administration (FDA) is one of the health authorities whose data is analyzed as part of RI. RI is important for ensuring compliance and competitiveness. It helps organizations adapt to the…
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FDA LDT Final Rule
The LDT final rule intends to improve patient safety by ensuring LDTs meet the same standards as other medical devices. The rule also provides wider exemptions than previously anticipated for LDTs already on the market. It includes a phased, five-stage “phase-out” of enforcement discretion over four years, demanding escalating compliance from labs, with certain exemptions for tests…
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ISO 13485 Explained
ISO 13485 is the internationally recognized quality management benchmark for medical device manufacturers. The ‘ISO’ in ISO 13485 stands for the International Organization for Standardization, which publishes the international standards governing most modern industries. Getting ISO 13485 certified guarantees the trust of regulators, stakeholders, and future customers while quickening route to market with ISO1345 compliance. ISO 13485 is an…
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FDA List of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
FDA posts a list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. It is so helpful in understanding the agency’s evaluation of appropriate study diversity based on the device’s intended use and technological characteristics.