chapter  14
21 Pages

NewMedical Device Approval Process in the United States

ByMax Sherman

BACKGROUND AND HISTORY There is the long-standing belief that the approval process for medical devices is much faster than the IND/NDA drug method. This is certainly true for Class I, Class II, and some pre-enactment Class III devices-products that can be cleared through premarket notification or 510(k) submissions. Such products are often approved for commercialization in 90 days or less. However, the difference in time is less apparent for manufacturers of new Class III products, where preclinical studies, clinical trials, and the premarket approval process are required. Statistics with respect to time of inception through time to market for new Class III devices is not readily available, but in the author’s opinion, it would be similar to that required for a new drug.