We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
In two new guidances, the FDA calls for different types of information in 510(k) premarket submissions for blood glucose monitoring systems for use by healthcare professionals as compared to those for home use by lay-users. Read More
A set of three guidance documents the FDA released Sept. 25 provides a look into the agency’s implementation of its new Accreditation Scheme for Conformity Assessment (ASCA) pilot program for devices. Read More
The design risk analysis for the firm’s infrared light therapy devices didn’t include an evaluation of all hazards that were “reasonably known,” the agency said. Read More
The system was chosen for the study “due to its record of increasing the efficacy of DNA vaccines and the speed of the delivery system compared to traditional needle and syringe,” the company said. Read More
The patch has “shown the potential to transform vaccine delivery with lower dose requirements, enabling more patient-doses to be manufactured more quickly from limited vaccine supply,” the company said. Read More
Early identification of patients at risk will “enable physicians to more aggressively monitor these patients in a controlled environment and provide earlier treatment,” the company said. Read More