{"id":389,"date":"2018-05-29T11:25:14","date_gmt":"2018-05-29T11:25:14","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/glossary\/medschool-glossary-investigational-device\/"},"modified":"2024-11-19T22:29:13","modified_gmt":"2024-11-19T22:29:13","slug":"investigational-device","status":"publish","type":"glossary","link":"https:\/\/az.research.umich.edu\/medschool\/glossary\/investigational-device\/","title":{"rendered":"Investigational Device"},"template":"","class_list":["post-389","glossary","type-glossary","status-publish","hentry"],"acf":{"glossary_term_description":"<p>A device permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing. Devices are classified as significant and non-significant risk. A significant risk device means an investigational device thatpresents a potential for serious risk to the health, safety, or welfare of a subject. (FDA)<\/p>","glossary_related_terms":"","legacy_glossary_node_id":622,"legacy_related_terms":""},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/glossary\/389","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/glossary"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=389"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}