{"id":434,"date":"2019-04-03T20:56:02","date_gmt":"2019-04-04T01:56:02","guid":{"rendered":"https:\/\/my.vanderbilt.edu\/forcebasedprosthesiscontroller\/?p=434"},"modified":"2019-04-03T20:57:31","modified_gmt":"2019-04-04T01:57:31","slug":"description-of-fda-category","status":"publish","type":"post","link":"https:\/\/my.vanderbilt.edu\/forcebasedprosthesiscontroller\/2019\/04\/description-of-fda-category\/","title":{"rendered":"Description of FDA Category"},"content":{"rendered":"<p><span style=\"font-weight: 400\">Because there are a variety of commercially-available powered and mechanical prosthetics, it is believed that this device should not require pre-market approval (PMA). Since this is a joint effort between our team and Case Western, it is understood that they will be responsible for bringing the product or certain components of this project to market. Many similar devices in this space have been approved in the past, so the process should be expedited. As of April 2018, the FDA classifies \u201cexternal limb prosthetic components\u201d as being Class I devices. These devices include but are not limited to \u201cankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves [1].\u201d Our project\u00a0falls under the criteria outlined above,\u00a0so we may (at most) require 510(k) approval.<\/span><\/p>\n<p>[1]\u00a0<span style=\"font-weight: 400\">\u201cCFR &#8211; Code of Federal Regulations Title 21.\u201d <\/span><i><span style=\"font-weight: 400\">Accessdata.fda.gov<\/span><\/i><span style=\"font-weight: 400\">,\u00a0<\/span><a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=890.3420\"><span style=\"font-weight: 400\">www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=890.3420<\/span><\/a><span style=\"font-weight: 400\">.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Because there are a variety of commercially-available powered and mechanical prosthetics, it is believed that this device should not require pre-market approval (PMA). Since this is a joint effort between our team and Case Western, it is understood that they will be responsible for bringing the product or certain components of this project to market&#8230;.<\/p>\n","protected":false},"author":7956,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-434","post","type-post","status-publish","format-standard","hentry","category-notebook"],"_links":{"self":[{"href":"https:\/\/my.vanderbilt.edu\/forcebasedprosthesiscontroller\/wp-json\/wp\/v2\/posts\/434","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/my.vanderbilt.edu\/forcebasedprosthesiscontroller\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/my.vanderbilt.edu\/forcebasedprosthesiscontroller\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/my.vanderbilt.edu\/forcebasedprosthesiscontroller\/wp-json\/wp\/v2\/users\/7956"}],"replies":[{"embeddable":true,"href":"https:\/\/my.vanderbilt.edu\/forcebasedprosthesiscontroller\/wp-json\/wp\/v2\/comments?post=434"}],"version-history":[{"count":2,"href":"https:\/\/my.vanderbilt.edu\/forcebasedprosthesiscontroller\/wp-json\/wp\/v2\/posts\/434\/revisions"}],"predecessor-version":[{"id":439,"href":"https:\/\/my.vanderbilt.edu\/forcebasedprosthesiscontroller\/wp-json\/wp\/v2\/posts\/434\/revisions\/439"}],"wp:attachment":[{"href":"https:\/\/my.vanderbilt.edu\/forcebasedprosthesiscontroller\/wp-json\/wp\/v2\/media?parent=434"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/my.vanderbilt.edu\/forcebasedprosthesiscontroller\/wp-json\/wp\/v2\/categories?post=434"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/my.vanderbilt.edu\/forcebasedprosthesiscontroller\/wp-json\/wp\/v2\/tags?post=434"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}