Premarket Overview

The FDA provides reasonable assurance that the product will be useful while not posing unacceptable risks to patients once device marketing begins. Operationally, this goal is accomplished through the FDA's use of regulatory controls and the classification process. General controls include device labeling, registration and listing, premarket notification, good manufacturing practices, and records and reports. Premarket notification requires any manufacturer intending to market a medical device to submit an application at least 90 days before beginning commercial distribution. The agency then determines if the device is substantially equivalent to a predicate device (meaning as safe and effective and for the same intended use). [New intended uses or significant changes in technology are potential reasons that a device may not be found substantially equivalent. In these cases, a Premarket Approval (PMA) submission may be required (see below).] Class I devices (such as heating pads or dentures) are those for which these controls alone are sufficient to assure the FDA of a product's safety and effectiveness.

Special controls are used in addition to general controls for higher risk Class II devices (such as hospital beds or surgical staplers). These controls include patient registries, guidances, and standards. Guidance documents are non-binding and assist industry in preparing regulatory submissions and FDA staff in the review process. They may interpret regulatory requirements, provide information on application content requirements for a specific device type, or convey guidance to sponsors on the development of preclinical and clinical data. Standards (both national and international), on the other hand, are developed through accredited standards development organizations with full participation of the government, industry, and academia. Most pertain to test methods for device evaluation or material specifications for type and quality of materials used in manufacturing. Manufacturers may declare conformity to FDA-recognized standards in a new device application.

When there is insufficient information to determine that general and special controls alone will reasonably assure safety and effectiveness, a product may be placed into Class III pending one other condition. The product must either be life-sustaining, life-supporting, or for use of a substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury [Section 513 (a)(1)(C), of the Federal Food, Drug, and Cosmetic Act (the Act)]. In addition to general and special controls, all Class III products (such as deep brain stimulators and cochlear implants) require the submission of clinical data in support of premar-ket submissions, known as PMA applications (in contrast to premarket notifications noted above).

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