premarket approval


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premarket approval

Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device.
References in periodicals archive ?
Although both of these substances are intended to be added to food, a food additive can only be used once a premarket approval has been granted by the FDA.
Throughout its existence, while exploring various alternative therapies, NCCAM has approached dietary supplements with the aim of steering as many as possible toward the FDA's drug approval process and its benefits of premarket approval and more accountable manufacturing.
The company is seeking PreMarket Approval from the Food and Drug Administration for its CTLM system to be used as an adjunct to mammography.
On March 25, 2004 the FDA's General and Plastic Surgery Devices Panel will hold a public hearing on "a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients." AIDS Treatment News has learned that the application is for Sculptra, which is marketed in Europe under the name New-Fill.
Nicotine Water, which has been available through the Internet for two years, is not currently regulated by the FDA, although a group of health organizations has petitioned the agency to require "premarket approval" of the product as a drug.
has filed a supplemental premarket approval application to the Food and Drug Administration for use of the GlucoWatch Biographer in children aged 7-17 years.
As a class II in vitro diagnostic medical device, the Dade Behring N High Sensitivity CRP assay referenced in these articles is not "approved" by the FDA per se, nor is premarket approval required.
Because FDA considers most GM foods to be substantially equivalent to their conventional counterparts, the agency again declined to require bioengineered products to undergo the same extensive premarket approval process required for food additives, or to require bioengineered products to be labeled.
clinical studies with CoSeal last month and anticipates filing a CoSeal Premarket Approval ("PMA") application with the FDA at the end of this year.
Although many of these studies have been completed, the data were submitted to the FDA under a premarket approval (PMA) application and are therefore confidential unless publicly released by the manufacturers.
The Eleventh Circuit's decision is important to plaintiff lawyers handling medical device products liability cases in that jurisdiction because it clarifies that manufacturers of devices that received premarket approval are not immune from liability for injuries caused by their products.
The Food and Drug Administration (FDA) this week filed the company's Premarket Approval (PMA) application for the product, triggering the final phase of regulatory review for possible commercial approval in the United States.