title: [Evaluation of new implantable medical devices].
abstract: Complex administrative procedures have gradually been established for the evaluation of implantable medical devices, resulting in improved patient safety. These procedures include in vitro testing, animal experimentation, clinical premarketing studies, and post-market surveillance. Further improvements are needed, however, including more independent experts and clinical studies, while ensuring that the approval process is neither to slow nor too hasty.
authors.affiliation: daniel.loisance@wanadoo.fr
authors.forename: Daniel
authors.initials: D
authors.lastname: Loisance
mesh_terms: D032761:Animal Experimentation; D000818:Animals; D002986:Clinical Trials as Topic; D003257:Consumer Product Safety; D018795:Device Approval; D005062:European Union; D006801:Humans; D011358:Product Surveillance, Postmarketing; D019736:Prostheses and Implants; D014481:United States; D014486:United States Food and Drug Administration