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ISPE Glossary of Pharmaceutical and Biotechnology Terminology
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Form 510(k)
Manufacturers of a new medical device need not file a premarket approval form if the device is “substantially similar” to an already approved device that did not require a premarket approval form. Instead manufacturers may file the simpler form 510(k). The 510(k) was supposed to be a premarket notification that did not require approval. In the years following 1976, the FDA began to require that more and more information be included with the 510(k) notification. Now the industry considers the 510(k) to be the first in a series of premarket approval hurdles, rather than a notification. With the passage of the SMDA in 1990, the 510(k) officially became a premarket approval regulation.
Publication Source: Committees on Human Research
See also: 510(K) Device
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