Medical Devices: PMA Approvals.

Author: United States Food and Drug Administration.

Source: FDA Website

Year: 2009

Comment:

This document explains how the FDA classified dental mercury amalgam in conformance with the mandate of the Medical Device Amendments of 1976.

Abstract / Excerpt:

“The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the act) established three regulatory classes for medical devices. The three classes are based on the degree of control necessary to assure that the various types of devices are safe and effective. The most regulated devices are in Class III. The amendments define a Class III device as one that supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury . Insufficient information exists on a Class III device so that performance standards (Class II) or general controls (Class I) cannot provide reasonable assurance that the device is safe and effective for its intended use. Under Section 515 of the act, all devices placed into Class III are subject to premarket approval requirements. Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices.”

Citation:

Medical Devices: PMA Approvals. United States Food and Drug Administration Website.  http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/pmaapprovals/default.htm. Updated 6/18/2009.