FDA Requirements & Review

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

From the Editor: Manufacturing & Prototyping

FDA is monitoring the emerging field of 3D printing and additive manufacturing, an area FDA once considered a “futuristic technology on the distant...

News: Connectivity
FDA Touts New AAMI Report on ‘Wireless Coexistence’ and Medical Devices

The Food and Drug Administration (FDA) is flagging a new technical information report (TIR) from AAMI that provides crucial guidance for “wireless coexistence” for a wide array of medical devices and systems.

R&D: FDA/Regulatory
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: Medical

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: FDA/Regulatory
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: Medical
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: FDA/Regulatory

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: FDA/Regulatory
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...

News: Medical
Can the FDA Successfully Spark Innovation in the U.S.?

At an estimated $105.8 billion, the U.S. medical device market may be the world's largest, but it could do with a healthy boost of innovation.* According to a recent White House blog post, "In trying to understand why the country’s pharmaceutical, biotech and medical device sectors seem to...

Ask the Expert

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.