Author: Lori
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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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Hearing Aid Feature (HAF)
The FDA has classified Apple’s new “air-conducting hearing aid feature” for AirPods Pro as an over-the-counter (OTC) hearing aid software, allowing users to utilize their existing AirPods as a hearing aid for mild to moderate hearing loss without requiring a prescription, marking the first time a company has received authorization for such a feature through the…
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The DiMe Seal for Digital Health Software Products
The Digital Medicine Society (DiMe) is a global non-profit and the professional home for all members of the digital medicine community. The group tackles Digital Health Software Products (DHSP) challenges, develops clinical-quality resources on a technology timeline, and delivers these actionable resources to the field via open-source channels and educational programs. Per the US FDA, digital…
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Biosecurity Compliance and Risk Management
The US federal government is taking steps to have better pandemic preparedness by enhancing regulations. Recent regulatory developments are addressing the need for the U.S. biomedical research community to strengthen biosecurity measures, especially with synthetic biology and research of potentially dangerous pathogens involving Pathogens with Enhanced Pandemic Potential (PEPP) or when artificial intelligence (AI) is…
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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…