ABSTRACT
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 preenactment 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 is required. Statistics with respect to time of inception through time to market for new Class III devices are not readily available, but in the author’s opinion it would be similar to that required for a new drug.
