Premarket review

FIFRA23 imposes a system of pesticide product registrations. Such requirements include premarket review of potential health and environmental effects before a pesticide can be introduced in the United States, reregistration of products introduced prior to the enactment of FIFRA to assess their safety in light of current standards, and classification of pesticides for restricted or general use. Restricted products can be used only by those whose competence has been certified by a state program. 

Single-site IVD "Home brew" or "in-house" IVD made with an analyte specific reagent FDA requires labeling disclosing the "in-house" nature of the test but has no premarket review requirement CLIA requires analytical validation and quality control systems... 

Commercial reagents for use in "home brew" tests Analyte specific reagents FDA most 510(k) exempt blood bank and high-public health-risk reagents subject to premarket reviews CLIA oversight of laboratories using these reagents... 

When an IVD is developed as a kit or system to be used with specific equipment and is sold to multiple laboratories, it is considered a device in interstate commerce and is subject to premarket review. When the IVD is a novel test, premarket approval (PMA) will be based on the analytical and clinical validation that will determine whether the test is safe and effective for clinical use. When there is evidence that the IVD is substantially equivalent to a legally marketed device, FDA clears such tests under section 510(k) of the Device Amendments to the Food, Drug and Cosmetic Act. The necessary level of evidence and requirements are described in more detail below. 

US-FDA performs premarket review of laboratory, animal, and human clinical testing for new human dmgs and biologies, complex medical devices, food and color additives, and animal dmgs for safety and effectiveness. Infant formulas are reviewed for required nutrient content and safety in manufacturing practices. 

For regulatory purposes, a combination product is assigned to an agency center or alternative organizational component that will have primary jurisdiction for its premarket review and regulation. Manufacturers will be required to use the applicable GMP for their products. Regulations that may apply are ... 

Because premarket review can t catch all potential problems with a drug, the FDA continues to track approved drugs for adverse events through a postmarketing surveillance program. 

In some cases using genetic engineering, plant breeders may introduce genes into food crops that encode substances that differ substantially in struclure and funclion front substances currently found in food. Based on current developments, such substances would be expected to be proteins or protein enzymes that modify carbohydrates and fatty acids in the food. In some cases, such substances will require premarket approval as food additives in other cases, the food may require new labeling to properly inform consumers of the new attributes of the food. However, in most cases to date, the substances that occur in food as a result of gene transfer have been safely consumed as food previously or are subslanlially similar to food substances and would not require premarket review by FDA. 

The FDA is responsible for the review and market approval of new drugs, biologies, and medical devices in the United States under the authority of the Federal Food Drug and Cosmetic Act (the Act) and Section 351 of the Public Health Service Act (the PHS Act). The FDA defines premarket review as the examination of data and information in an application as described in Sections 505, 510(k), 513(f), 515, or 520(g) or 520(1) of the Act or Section 351 of the PHS Act. This refers to the premarket review of data and information contained in any Investigational New Drug application (IND), Investigational Device... 

As illustrated in Fig. 9-1, pharmaceuticals and other medical products today are developed and used within a complex system involving contributions from numerous stakeholders, including manufacturers who develop and test products, the Food and Drug Administration (FDA) through its premarketing review and approval process and postmarketing surveillance programs, health care providers, and patients. 

In Canada and the United States, the food additive petition processes are similar and require premarket review and approval. In the United States, under the proposed GRAS Notification rule, a manufacturer can declare that a substance is GRAS if there is scientific consensus among qualified experts about its safety under the conditions of intended use. The manufacturer then notifies FDA, and if the agency has no questions, a letter of no objection is issued. 

The category combination products also includes those products consisting of cells/ tissue combined with a device and/or drug (such as cells on a natural or synthetic matrix) that, in general, have been termed human cellular- and tissue-based products. In the US these products have two possible routes to the clinic. The first route is referred to the 361 pathway and does not require premarket review. Only some products... 

When the U.S. Congress enacted the "Food Additives Amendment" (s. 409) to the U.S. Federal Food, Drug, and Cosmetic Act in 1958, a premarket review system for food additives was established. This included a food additive that could be expected to become a component of food because of its use in food contact articles, such as food packaging. Although it might be expected that lead would be included in this category. Congress defined "food additive" (s. 201 (s) of the Act (21 U.S.C. 

Although different authorities have different systems of premarket review, they all apply a similar risk-management philosophy in which all medical devices must satisfy safety and performance, quality system, and labeling requirements. The degree of regulatory scrutiny increases with the potential risks of the medical device, as evidenced by the risk-based device classification system proposed by the GHTF. 

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