Sentence examples for premarket approval from inspiring English sources

Class III Medical Device(s) requiring a Premarket Approval (PMA) have also been approved in this area for use in templating Class III implant systems.

To evaluate and compare the recall rates of obstetric and gynecologic devices approved via the Food and Drug Administration's 510(k) and premarket approval (PMA) processes.

Our results may not be generalisable to therapeutics that were not approved by the FDA or to lower-risk ophthalmic devices, for which premarket approval is not required.

The device won F.D.A. premarket approval in 1994, two years before the incident.

The purpose, she said, was to prevent individual states from imposing their own premarket approval process on new medical devices.

Devices subject to the premarket approval process, and thus affected by the court's opinion, tend to be more technologically advanced, expensive and, in some instances, risky.

The case before the court concerned only medical devices that had gone through the premarket approval process specified by the Medical Device Amendments of 1976.

Two lower federal courts in New York dismissed the suit on the ground that the F.D.A.'s "premarket approval" precluded the imposition of liability under state law.

Premarket approval was not "irrelevant to the tort suit" but was not by itself adequate to invoke pre-emption, Ms. Zieve said.

They want them to be considered dietary supplements, which do not need the F.D.A.'s premarket approval and are not required to be proved safe or effective.

Ms. Zieve, a lawyer with the Public Citizen Litigation Group, conceded that the law would prevent a state from imposing its own premarket approval process that differs from the federal one.