BIO 230 Lecture Notes - Lecture 7: Ce Marking, Medical Device, Percutaneous

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

Document Summary

Knowing the applicable regulation and product code (as described above) is necessary for you to determine the classification of your medical device. Once you have this information, you will now be able to determine the path to get your product registered with fda. Here are the options: class i (low to moderate risk): general controls, class ii (moderate to high risk): general controls and special controls, class iii (high risk): general controls and premarket approval (pma) If you find your product is exempt, then only general controls apply and no formal fda submission is required. You do, however, need to register your establishment with fda and then list the product. If you find your product requires special controls, this means you will have to prepare a 510(k) submission to fda and receive clearance before going to market. And then need to register your establishment and list the product.