Sentences with phrase «safety analysis purposes»

Not exact matches

«Not only do we believe that high - quality, randomized clinical trials are necessary to determine the safety of the Lariat device for off - label procedures, but our analysis raises broader issues with the FDA 510 (k) clearance protocol for medical devices,» said study senior author Jay Giri, MD, MPH, assistant professor in the Cardiovascular Medicine Division at Penn. «We believe there needs to be a method for reassessing the safety of a device that has been cleared for one use but is being frequently used for a different purpose in real - world practice.»

The topics on which we believe additional information and analysis are necessary include the purpose and need for the project, potential greenhouse gas emissions associated with the project, air pollutant emissions at the receiving refineries, pipeline safety / spill response, potential impacts to environmental justice communities, wetlands and migratory birds.

The majority of the Court of Appeal, in dismissing the appeal, rested their analysis on whether the requirement was justified by purposes under the Traffic Safety Act (this did not include reducing identity theft or other security interests) and as far as these were concerned, the requirement did not minimally impair the Hutterites» freedom of religion.