Categories |
Description |
Pre-amendment |
devices that were marketed prior to May 28, 1976 (the date the MDA was signed into law) |
Post-amendment |
devices that were approved by the FDA after the MDA was enacted |
Substantially Equivalent |
devices that are substantially equivalent to pre-amendment devices based on their design, materials, and intended use |
Implant |
devices that are inserted into a surgically formed or natural body cavity and intended to stay for at least 30 days. |
Custom |
devices generally not available to other licensed practitioners and not available in finished form |
Investigational |
devices undergoing clinical investigation under the authority of an Investigational Device Exemption from the FDA |
Transitional |
devices which were regulated as drugs prior to the Medical Device Amendments but are since regulated as devices |