The 'de novo' 510(k) process may be accepted by FDA for low and medium risk devices for which no legally marketed predicate device exists.
 
 
A substantial amount of data, including clinical data, is usually required before FDA will clear a device under the de novo process, and the timescales involved are often extended.
 
 
GEMAR can assist by assessing the likelihood of a new device being accepted onto the de novo program, and by helping to develop the necessary documentry evidence of device sfaety and effectiveness.