BIO 230 Lecture Notes - Lecture 7: Office Of In Vitro Diagnostics And Radiological Health, Medical Device, Food And Drug Administration

• School: Cal Poly Pomona
• Department: Biology
• Course: BIO 230
• Professor: Jon Olson

Document Summary

Knowing how your medical device is classified matters for the following reasons: product classification will determine what you have to do before you can sell your product. Product classification will help you establish what is required during product development and. Product classification is an important component in determining how much it will cost to bring your product to market and give you some idea of how long it will take. In the united states, medical devices are regulated by food & drug administration, of fda. The specific branch within fda is center for devices & radiological health (cdrh). Cdrh is to protect and promote public health. In other words, ensure medical devices are safe. Medical devices are either class i, class ii, or class iii. The fda cdrh classification is based primarily on risk the medical device poses. Class i are generally deemed low risk and class iii highest risk.