%0 Journal Article %T Orphan devices: yesterday is history; tomorrow is mystery: towards a European orphan device directive? %A Marc M Dooms %J Archive of "Orphanet Journal of Rare Diseases". %D 2016 %R 10.1186/s13023-016-0393-3 %X Regulatory and economic frameworks stimulated the research and development of orphan drugs, but very little has been done for devices necessary for the in-vivo diagnosis, prevention and treatment of life-threatening conditions with a low prevalence/incidence %K History of medicine %K Rare diseases %K Orphan drugs %K Custom-made medical devices %K Humanitarian-use devices %U https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4778287/