Premarket Overview

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Chapter: Pharmacovigilance: Surveillance for Medical Devices - USA

The FDA provides reasonable assurance that the product will be useful while not posing unaccept-able risks to patients once device marketing begins.


The FDA provides reasonable assurance that the product will be useful while not posing unaccept-able risks to patients once device marketing begins. Operationally, this goal is accomplished through the FDA’s use of regulatory controls and the classi-fication process. General controls include device labeling, registration and listing, premarket notifica-tion, good manufacturing practices, and records and reports. Premarket notification requires any manufac-turer 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 predi-cate device (meaning as safe and effective and for the same intended use). [New intended uses or signifi-cant 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 indus-try in preparing regulatory submissions and FDA staff in the review process. They may interpret regula-tory 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 organiza-tions with full participation of the government, indus-try, and academia. Most pertain to test methods for device evaluation or material specifications for type and quality of materials used in manufacturing. Manu-facturers 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 reason-ably 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 clin-ical data in support of premarket submissions, known as PMA applications (in contrast to premarket notifi-cations noted above).

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