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.
The FDA issued a report to Congress on the results of mandatory training given to its premarket device review staff on applying the least burdensome requirements in product reviews. Read More
The FDA released draft guidance with recommendations for 510(k) submissions of guidewires intended for use in coronary, peripheral and neurovasculature procedures, including recommendations for biocompatibility tests. Read More
As part of its efforts to reduce regulatory burdens on devicemakers and to implement provisions of the 21st Century Cures Act, the FDA issued a final… Read More
The Supreme Court ruled that the industry should comply with the summary of safety and clinical performance required under the EU’s 2017 Medical Device Regulation. Read More