{"id":13539,"date":"2020-01-22T17:01:04","date_gmt":"2020-01-22T16:01:04","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=13539"},"modified":"2023-01-24T14:59:14","modified_gmt":"2023-01-24T13:59:14","slug":"usa-no-longer-paper-copies-for-510k","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2020\/01\/22\/usa-no-longer-paper-copies-for-510k\/","title":{"rendered":"USA: no longer paper copies for 510(k)"},"content":{"rendered":"\n<p>On January 15, 2020 the&nbsp;FDA Guidance \u201c<a href=\"https:\/\/www.federalregister.gov\/documents\/2019\/12\/16\/2019-27047\/medical-device-submissions-amending-premarket-regulations-that-require-multiple-copies-and-specify\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format<\/a>\u201d came into force, amending formal requirements (paper and electronic copies management) also for 510(k) Premarket submissions.<\/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-8959\"\/><figcaption>No longer paper copies for 510(k)<\/figcaption><\/figure>\n\n\n\n<p>In accordance with the Executive Orders (Eos) <a rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\" href=\"https:\/\/www.federalregister.gov\/documents\/2017\/02\/03\/2017-02451\/reducing-regulation-and-controlling-regulatory-costs\" target=\"_blank\">13771<\/a>&nbsp;and&nbsp;<a href=\"https:\/\/www.federalregister.gov\/documents\/2017\/03\/01\/2017-04107\/enforcing-the-regulatory-reform-agenda\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">13777<\/a>, this provision intends to reduce paper and multiple copies in favor of a single dossier\u2019s submission in electronic form. Moreover, the Guidance reduces the number of electronic copies required by the Agency as easily reproducible, thereby improving and streamlining the medical device submission program. <\/p>\n\n\n\n<p>Submissions\nin electronic form are intended both eCopies, i.e. on CD, DVD or flash drive\ncreated and forwarded practices then submitted to FDA, and eSubmissions or\ndocumentation relays deriving from an electronic submission template.<\/p>\n\n\n\n<p>The regulations will apply not only to Premarket Notification Submissions (510(k)) pursuant 21 CFR 807.90, but also to&nbsp; Confidentiality of Information Certifications (21 CFR 807.95), Investigational Device Exemption (IDE) applications (21 CFR 812.20), Premarket Approval Applications (PMAs) (21 CFR 814.20), PMA supplements (21 CFR 814.39) and Humanitarian Device Exemption (HDE) Applications (21 CFR 814.104).<\/p>\n\n\n\n<p>The rules\nwill apply both to devices managed by the Center for Devices and Radiological\nHealth (CDRH) and the Center for Biologics Evaluation and Research (CBER) and\nit will be immediately effective.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On January 15, 2020 the&nbsp;FDA Guidance \u201cMedical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To  [&#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],"tags":[],"class_list":["post-13539","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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