Sentence examples for approval of a device from inspiring English sources
Now the Bush administration argues that the agency's approval of a device "sets a ceiling as well as a floor".
That began to change last April, when the FDA fast-tracked the approval of a device called Evzio.
A multisite clinical validation study and regulatory approval of a device based on a similar technology would likely facilitate harmonization of BCR ABL1 quantitative measurement, improve clinical laboratories' efficiency and workflow, and increase adherence to the current recommendations for reporting on the IS.
In September 2007, the United States Congress passed Title III of the FDA Amendments Act, The Pediatric Medical Device Safety and Improvement Act, requiring that new applications or protocols submitted to the FDA for the use and approval of a medical device must include a description of any pediatric subpopulation that suffers from the condition that the device will treat, diagnose, or cure [ 68].
At that time, the government said that F.D.A. approval of a medical device set the minimum standard, and that states could provide "additional protection to consumers".
That is because the approval of a new device can begin a process in which a start-up company is acquired by a larger manufacturer and early investors profit by cashing out.
Unfortunately, it's a problem that needs an immediate resolution, and regulatory approval of a new device is anything but immediate.
Some foreign companies conduct the first surgeries in India after the approval of a medical device or surgical treatment by their home authorities.
For example, the most recent PMA approval of a PSA device for diagnosis of prostate cancer (Access® Hybritech® p2PSA), the sponsor performed a clinical study using a 658-member patient cohort of mostly prospectively enrolled subjects, both with and without prostate cancer.
In 2004, the administration reversed longstanding federal policy and began arguing that "premarket approval" of a new medical device by the F.D.A. overrides most claims for damages under state law.
Both the Institute of Medicine and the Association of American Medical Colleges say physician-scientists who stand to gain financially from FDA approval of a drug or device should stay out of the clinical trials.
