{"id":240,"date":"2020-07-09T10:32:53","date_gmt":"2020-07-09T14:32:53","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=240"},"modified":"2020-07-09T10:32:53","modified_gmt":"2020-07-09T14:32:53","slug":"fda-issues-guidance-on-procedures-for-device-establishment-inspections","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2020\/07\/09\/fda-issues-guidance-on-procedures-for-device-establishment-inspections\/","title":{"rendered":"FDA Issues Guidance on Procedures for Device Establishment Inspections"},"content":{"rendered":"<p>On June 29, 2020, the U.S. Food &amp; Drug Administration (FDA) issued guidance on how it will implement certain inspection procedures with respect to device establishments\u2014facilities where medical devices are manufactured. The FDA\u2019s guidance contains recommendations about (1) preannouncement notice (and communications prior to an establishment inspection); (2) inspection durations and timeframes; and (3) communications between the establishment\u2019s representative and FDA\u2019s inspector(s) during the inspection process.<\/p>\n<p>To read the full text of this Duane Morris <em>Alert<\/em>, please <a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_issues_guidance_procedures_device_establishment_inspections_0720.html\" target=\"_blank\" rel=\"noopener noreferrer\">visit the firm website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On June 29, 2020, the U.S. Food &amp; Drug Administration (FDA) issued guidance on how it will implement certain inspection procedures with respect to device establishments\u2014facilities where medical devices are manufactured. The FDA\u2019s guidance contains recommendations about (1) preannouncement notice (and communications prior to an establishment inspection); (2) inspection durations and timeframes; and (3) communications &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2020\/07\/09\/fda-issues-guidance-on-procedures-for-device-establishment-inspections\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Issues Guidance on Procedures for Device Establishment Inspections&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[29,318,323,468],"ppma_author":[521],"class_list":["post-240","post","type-post","status-publish","format-standard","hentry","category-general","tag-fda","tag-inspection","tag-medical-devices","tag-u-s-food-drug-administration"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/240","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=240"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/240\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=240"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=240"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=240"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=240"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}