FDA Requirements & Review

Explore Medical Device FDA guidelines and requirements for labeling, training, distributing, tracking, and reporting.

R&D: Medical
FDA-Approved Algorithm Detects Hemorrhagic Shock

Researchers from the U.S. Army Institute of Surgical Research collaborated with scientists and engineers at the University of Colorado and Flashback Technologies, Inc., to develop an algorithm, the Compensatory Reserve Index (CRI), to detect when a patient experiences hemorrhagic shock, a leading...

Features: FDA/Regulatory

Design validation is one of the most important aspects of the design and development process for medical devices. It is at this stage that the medical device manufacturer confirms that the device...

INSIDER: FDA/Regulatory

Dr. Robert M. Califf, a cardiologist, researcher, and founder of the Duke Clinical Research Institute, was confirmed by the Senate on February 24 as the next Commissioner of the U.S. Food and...

INSIDER: Medical
FDA Announces First Patient Engagement Advisory Committee

While historically, the development of new technologies to improve patients’ lives has relied upon experts’ opinions rather than asking patients and families directly what they consider important, this may be about to change. Patients and their care partners are becoming intimately...

INSIDER: FDA/Regulatory
FDA Revises Fees for Medical Device Export Certificates

The Emergo Group recently posted an advisory that the FDA has revised the fee charged for issuing medical device export certificates in response to higher costs and demand for these documents.

Features: Medical

Medical device manufacturers frequently face unique industry challenges, including the need to manage quality processes across disparate sites or...

Features: FDA/Regulatory

Many medical devices, both existing and new designs, are laser-based. For some time, lasers have been designed into medical devices from...

News: Medical
CHOP and Drexel Team Up to Create Medical Devices for Children

Medical devices are not always one size fits all, especially with regard to child-sized devices. The Philadelphia Regional Pediatric Medical Device Consortium (PPDC) brings together engineers and biomedical researchers from the Children’s Hospital of Philadelphia (CHOP), Drexel...

Features: FDA/Regulatory

The recent publication by the U.S. Food and Drug Administration (FDA) of Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers, dated June of 2012, the Department of...

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Ralph Bright on the Power of Power Cords

Understanding power system components and how to connect them correctly is critical to meeting regulatory requirements and designing successful electrical products for worldwide markets. Interpower’s Ralph Bright defines these requirements and explains how to know which cord to select for your application.

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