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premarket approval

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An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification submission to Food and Drug Administration (FDA).
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Food additives are not automatically required to get premarket approval by the US Food and Drug Administration.
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Premarket approval requires data showing that a device is safe and effective.
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Cosmetic products and ingredients do not need FDA premarket approval, with the exception of colour additives.
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Cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives.
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Expedited Access for Premarket Approval Medical Devices
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Class III devices require Premarket Approval (PMA)
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Failure to have premarket approval or clearance for such devices is a violation of U.S. law.
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Such a device would require premarket approval by the agency.
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Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives.
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Premarket approval by the Food and Drug Administration (FDA) are not required unless specific disease prevention or treatment claims are made.
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The FDA evaluated the BRACAnalysis CDx’s safety and efficacy under the agency’s premarket approval pathway used for high-risk medical devices.
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No "If the use of a food substance is GRAS, is not subject to premarket approval requirement and the FDA review.
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No "If the use of a food substance is GRAS, is not subject to premarket approval requirement and the FDA review.).
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In March 2014, the FDA recommended premarket approval, a process of scientific and regulatory review to evaluate safety and effectiveness, for this test.
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"Both phenylephrine and pseudoephedrine are generally recognized as safe and effective and may be marketed without premarket approval by the FDA," Fischer said.
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The FDA reviewed data for the VenaSeal system in a premarket approval application, the agency’s pathway to evaluate safety and effectiveness of Class III medical devices.
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• ZOLL ResQCPR System receives premarket approval from the FDA; shown to profoundly increase blood flow to the heart and other vital organs in pre-clinical studies.
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Also, chondroitin sulfate has been given premarket approval by the US Food and Drug Administration (FDA) to be used as an eye solution during cataract surgery.
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Like all “Class III” medical devices, which the government believes could present “a potential, unreasonable risk of illness or injury,” Essure underwent the FDA’s Premarket Approval process.
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Our FCR for mammography obtained its Premarket Approval (PMA) from the Food and Drug Administration (FDA). The FCR is able to offer world class quality and effective workflow.
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The CustomFlex Artificial Iris was approved through a premarket approval application (PMA), which is the most stringent type of device marketing application and generally required for high-risk devices.
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This means that only after a product is considered harmful, adulterated or misbranded FDA regulatory action.The only cosmetic ingredients that require premarket approval from the FDA are taken are color additives.
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“We are very excited that the BRACAnalysis CDx is the FDA’s first approval of an LDT under a premarket approval application and is the first approval of an LDT companion diagnostic.
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"Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives ... Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing."
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