Sentence examples for premarket review from inspiring English sources
However, if a test is developed by a clinical laboratory for use at its own facilities, it can be sold without a premarket review.
Based on material found on the computers, the F.D.A. concluded the employees violated federal law by disclosing confidential information submitted by manufacturers in the agency's premarket review process.
The American public and patients in particular need to know that the F.D.A.'s premarket review process is a risk-based, science-driven method for determining the safety and effectiveness of medical devices.
"Premarket review allows for an independent and unbiased assessment of a diagnostic test's ability to generate test results that can reliably be used to support good health care decisions," Alberto Gutierrez, who leads diagnostic test regulation at the F.D.A., wrote in the letters.
This not only applies to premarket review, but also to manufacturing quality during production.
One area of controversy is when a change to the design of the cigarette pack requires approval through FDA's rigorous premarket review process.
Tumor markers may be reviewed as 510(k) submissions or as premarket approval application (PMA) submissions or may be exempt from premarket reviews.
The FDA's classification and premarket reviews of first generation engineered tissue products have demonstrated that it is actively engaged in developing rational product approval pathways for engineered tissue products.
Subsequently, and during the premarket approval review, updated data from the PREVIAL study revealed more ischemic strokes in the WATCHMAN group, corresponding to a total of 13 ischemic strokes in the WATCHMAN group versus 1 in the control group.
Compares premarket priority review status from Health Canada to postmarket therapeutic status as assessed by two independent organisations.
Its responsibilities include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.
