Design & Testing

A final guidance, “Design Considerations for Devices Intended for Home Use,” issued by the FDA, is intended to assist manufacturers in designing and developing home-use devices that comply with applicable standards of safety and effectiveness and other regulatory requirements.

Scientists at the National Institute of Standards and Technology, Gaithersburg, MD, in collaboration with the National Cancer Institute and the Radiological Society of North America, have designed and developed image-calibration technology to study the effects of traumatic brain injury (TBI). The...

To strengthen the safety of medical devices, the FDA has finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. On October 1, the agency issued a final guidance on the content of premarket submissions for the management of...

New research has confirmed that a technique developed previously at the National Institute of Standards and Technology (NIST) Gaithersburg, MD, can enable optical microscopes to measure the 3D shape of objects at nanometer-scale resolution—far below the normal resolution limit for optical...

On August 13, The FDA issued a guidance for industry and FDA staff called “Unique Device Identification System: Small Entity Compliance Guide”. This guidance is intended primarily to provide information to the medical device industry, including small businesses, concerning FDA’s September...

The U.S. Food and Drug Administration has issued new draft guidance that would exempt certain Class I and Class II medical devices from premarket, or 510(k),submission requirements. If a device is “exempted from premarket notification,” then the FDA would allow a device that was...

UL (Underwriters Laboratories), Northbrook, IL, announced that the FDA has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium or nickel-based batteries. The two standards are UL 2054 - Standard for Household and Commercial...

A team of nuclear engineers at Oregon State University, Corvallis, say that they have developed a small, portable, and inexpensive radiation detection device to help users understand whether or not their surroundings pose a health risk. They say that the technology used in the new device provides...

Recognizing that the need for effective cybersecurity to ensure medical device functionality has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information, the FDA has issued a draft...

The U.S. Food & Drug Administration (FDA) has issued the first phase of its Global Unique Device Identification Database (GUDID): Guidance for Industry on June 11, 2014. To quickly provide industry with information critical to successful use of the GUDID, the FDA is issuing the GUDID Guidance in two...