Pre-amendment devices

Key words pre-amendment device, labeling, premarket approval. Quality System Regulations, engineered nanomaterials. 

Before a manufacturer may introduce into commerce any medical device it has not previously marketed, the manufacturer must submit to the FDA a premarket notification. This notification requirement is designed to assure that manufacturers do not intentionally or unintentionally circumvent the automatic classification into class III of devices not on the market prior to enactment of the Medical Device Amendments and not substantially equivalent to pre-amendment devices. 

PMA requirements differ between pre-amendment and post-amendment devices. Pre-amendment devices are those in commercial distribution before May 28, 1976 ... 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

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