{"id":8962,"date":"2019-03-01T17:13:48","date_gmt":"2019-03-01T16:13:48","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8962"},"modified":"2023-01-24T15:02:06","modified_gmt":"2023-01-24T14:02:06","slug":"nonbinding-feedback-on-corrective-actions-originating-from-medical-device-establishment-inspections-fda-proposes-standardized-approach","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2019\/03\/01\/nonbinding-feedback-on-corrective-actions-originating-from-medical-device-establishment-inspections-fda-proposes-standardized-approach\/","title":{"rendered":"Nonbinding feedback on corrective actions originating from medical device establishment inspections: FDA proposes standardized approach"},"content":{"rendered":"\n<p>In an effort to address safety and quality issues emerged during medical device establishment inspections as quickly and adequately as possible, on February 19, 2019, the US FDA issued a draft guidance titled \u201c<em><a href=\"https:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM631397.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Nonbinding Feedback After Certain FDA Inspections of Device Establishments<\/a><\/em>\u201d, in compliance with section 702 \u201c<em>Improvements to inspections process for device establishments\u201d <\/em>of the FDA Reauthorization Act of 2017 (FDARA). <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/03\/Nonbinding-feedback-on-corrective-actions-originating-from-medical-device-establishment-inspections-FDA-proposes-standardized-approach-1024x536.png\" alt=\"\" class=\"wp-image-8958\"\/><figcaption><em>Nonbinding feedback on corrective actions originating from medical device establishment inspections: FDA proposes standardized approach<\/em><\/figcaption><\/figure>\n\n\n\n<p>The draft guidance proposes a standardized\nprocess through which stakeholders (\u201c<em>owner,\noperator or agent in charge<\/em>\u201d of the device establishment) can request\nnonbinding feedback on the observations documented on the Inspectional\nObservations Form (Form FDA 483), released by the FDA upon completion of a\npremarket and\/or postmarket device establishment inspection.<\/p>\n\n\n\n<p>The submission of the request for nonbinding\nfeedback is to be made \u201c<em>in a timely\nmanner<\/em>\u201d, within 15 business days after Form 483 is issued. FDA intends to\nprovide its response within 45 calendar days or notify the company within that\ntime if the request is not eligible for the feedback. <\/p>\n\n\n\n<p>Stakeholders\nare invited to submit their comments and opinions on the matter until April 20,\n2019. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>In an effort to address safety and quality issues emerged during medical device establishment inspections as quickly and adequately as possible,  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2,1513],"tags":[],"class_list":["post-8962","post","type-post","status-publish","format-standard","hentry","category-news-en","category-us-agent-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Nonbinding feedback on corrective actions originating from medical device establishment inspections: FDA proposes standardized approach - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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