Sentence examples for approval of devices from inspiring English sources

With new requirements added to the approval of devices, it could make it much harder to get devices approved.

The agency Thursday issued draft guidelines that, when finalized this year, will allow the FDA to block approval of devices if manufacturers don't provide adequate plans for protecting them.

3 4 FDA documents containing the evidence to support approval of devices are available but are not easy to access.

The F.D.A. is in the midst of a wide-ranging reassessment of its device approval process and released a report Aug. 4 that highlighted some of its flaws, including approvals of devices modeled on unsafe or obsolete predecessors.

"When you look historically at the approvals of devices that have specific pediatric indications, they're abysmal — essentially flat-lined," said James Wall, MD, assistant professor of surgery, who leads the Stanford side of the collaboration.

The Centers for Medicare and Medicaid Services, the agency that administers Medicare, said that none of the clinical trials used to gain F.D.A. approval of the devices included patients over 60, leaving Medicare with no basis for saying the devices were a reasonable or necessary therapy for such patients.

The bar for approval of medical devices is too low.

Approval of medical devices and drugs was delayed.

Submissions to regulatory bodies for approval of medical devices must include the results of biological evaluation.

The difficulties of design and construction of miniaturized blood pumping systems and the high costs associated with developing, testing, and approval of such devices has been prohibitive.

The conduct of COMPANION was challenged by important issues that arose during the trial, the most important of which was U.S. Food and Drug Administration approval of CRT devices.