Research and Development

ARTICLES

3D Printing Set to Transform Device Industry, Experts Say

3D printing is poised to transform the medical device industry, according to several players in the space who participated in a recent FDAnews webinar. Read More

UVLrx Therapeutics Flagged for IDE Violations

The FDA warned investigational medical device sponsor UVLrx Therapeutics for eight violations an FDA investigator observed during an inspection of its Florida facility from March 27 through April 4. Read More

FDA Clears First Medical Device Development Tool

A clinical outcome assessment questionnaire for measuring health outcomes reported by patients with congestive heart failure or weakened heart muscle became the first FDA-qualified medical device development tool. Read More

CDRH Extends Experiential Learning Program for 2018

CDRH is extending its Experiential Learning Program for agency staff into 2018 and is calling for submissions from potential participants. Read More

Apple, Fitbit Among FDA’s Picks for Device Software Pre-Certification Pilot

The FDA announced the nine participants selected for its first digital health software pre-certification pilot program, ranging from… Read More

GAO Flags Technical Challenges for Disease Diagnostic Devices

Government Accountability Office researchers visited eight devicemakers in connection with a new report on diagnostic medical devices and found that the regulatory review process poses an obstacle to applying the technology in the marketplace. Read More

Early Ergonomics Studies Can Help Combination Product Development

Early human-factor studies can address many questions on usability before combination products enter clinical testing, according to John Towns, a senior research fellow at Eli Lilly & Co. Read More

FDA Recommends Risk-Based Animal Testing of Organ Preservation Devices

Developers of medical devices designed to preserve organs for transplant should carefully evaluate the risk of injury to the organs as they test the devices with animal subjects, whether they measure outcomes in vivo or ex vivo, the FDA says in new draft guidance. Read More

FDA to Expand High Performance Computing to Boost Clinical Trial Efficiency

The FDA plans to expand its capabilities in high performance computing to help build disease models and simulate device clinical trials as part of an agency… Read More

WHO to Develop Essential Diagnostics List

The World Health Organization is developing an Essential Diagnostics List to help countries create their own national lists of essential diagnostic tests and tools. Read More