Design & Testing

A group of Korea Advanced Institute of Science and Technology (KAIST) researchers explored how the attractive physical features of zinc oxide (ZnO) materials could be more effectively used to tap into abundant mechanical energy sources to power micro devices.

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The U.S. Food and Drug Administration has issued new draft guidance that would exempt certain Class I and Class II medical devices from premarket, or 510(k),submission requirements.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...