513(g) Submission, medical device classification, CDRH, USFDA

Generally, Medical Devices classification in the United States of America is carried out according to a predicate system. That is drawing comparisons to legally marketed devices and determining classification of I, II, or III based on the risk. To enable manufacturers determine the classification of their device or to search for Substantially Equivalent (SE) of their devices, FDA provides a Medical Device classification database.

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