{"id":4751,"date":"2016-09-29T10:18:38","date_gmt":"2016-09-29T08:18:38","guid":{"rendered":"http:\/\/www.thema-med.com\/ee-uu-quedate-despierto-habla-fda\/"},"modified":"2023-01-25T17:01:06","modified_gmt":"2023-01-25T16:01:06","slug":"usa-wake-up-fda-is-speaking","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2016\/09\/29\/usa-wake-up-fda-is-speaking\/","title":{"rendered":"USA: wake up\u2026 FDA is speaking!"},"content":{"rendered":"<p>Speaking of novelties and regulatory updates, we can certainly assert that the FDA never sleeps!<\/p>\n<p>Agency is always frenetically busy in issuing new guidelines or documents, helping manufactures and regulators to understand how to comply with the US Regulation on devices.<\/p>\n<p>Keeping up is getting harder. Therefore, let\u2019s take a moment to analyze the<strong> latest and most significant four updates<\/strong>.<\/p>\n<p><strong>1. NEVER FORGET THE ANNUAL FEES!<\/strong><\/p>\n<p>Recently the FDA published <strong>fiscal year 2017 fees<\/strong>, starting from October 1st, 2016 until September 30, 2017. Unexpectedly, we can notice a taxes reduction relating to different practices. For example, the 510(k) fee is $2.345, while on 2016 it was $2.614; the Establishment registration fee is $3.382 against $3.845 in 2016.<\/p>\n<p><strong>2. THAT\u2019S GREAT!<\/strong><\/p>\n<p>After a prolonged silence since the guideline issuance, the FDA finally stated on July 29t that <strong>\u201cGeneral Wellness products\u201d are exempt from medical devices Regulation <\/strong>. The new \u201cGeneral Wellness: Policy for Low Risk Devices\u201d guideline has been published and it clarifies that FDA is not going to revise, neither approve, low-risk devices for general well-being, such as wearable monitors for physical activity or sleep tracing systems, and will therefore no longer require manufacturers of such product types to comply with medical device Regulation pre-market and post-market requirements.<\/p>\n<p><strong>3. DESIGN CHANGE: A LOVE-HATE RELATIONSHIP!<\/strong><\/p>\n<p>There are other changes in the air to manage modifications following the Marketing Clearance \u2013 510(k). In particular, the FDA has recently introduced <strong>two new guideline drafts<\/strong>, and one of them is entitled \u201cDeciding When to Submit a 510(k) for a Change to an Existing Device\u201d, that is a revision of the previous one and relates to changes to already approved medical devices which require a new FDA revision and therefore a <strong>new 510(k)<\/strong>. In particular, the guideline clarifies how the risk analysis can be used to evaluate whether the device modification involves the need of another FDA revision; it also provides further recommendations to prepare rational justifications if it is considered that the modification should not be submitted to the FDA.<br \/>\nThe other guideline, however, is new (entitled \u201cDeciding When to Submit a 510(k) for a Software Change to an Existing Device\u201d) and it refers specifically to the changes made on the software, defining more clearly what are the software modification requiring a new 510(k) and which ones can be managed on the Quality system level. (Did you read \u201c<a href=\"http:\/\/www.thema-med.com\/es\/software-medicale-in-qualita\/\">&#8220;4 steps to manage a SaMD \u201cin terms of quality&#8221;&#8221;<\/a>?). All taking a critical eye to <strong>Cybersecurity<\/strong>.<\/p>\n<p><strong>4. WATCH OUT FOR UDI!<\/strong><\/p>\n<p>The deadline for <a href=\"http:\/\/www.thema-med.com\/es\/come-implementare-efficacemente-il-programma-unique-device-indentification-udi-fda\/\">UDI compliance and class II devices registration to GUDID <\/a> is approaching, and the FDA always issues new updates for labelers and manufactures. In fact, a guideline draft was released and it is called \u201cUnique Device Identification System: Form and Content of the Unique Device Identifier (UDI)\u201d. The objective is to clarify the correct format and representation of the UDI code as well as its content.<\/p>\n<p>Do you want other information about USA? Go to the section Country <a href=\"http:\/\/www.thema-med.com\/es\/registrazione-di-un-dispositivo-medico-negli-stati-uniti\/\">USA<\/a><\/p>\n<p>Would you like to be always updated about Thema\u2019s activities? Sign up to our\u00a0<strong><a href=\"http:\/\/www.thema-med.com\/newsletter\/\">newsletter<\/a><\/strong>!<\/p>\n<p style=\"text-align: justify;\"><strong><img decoding=\"async\" class=\" wp-image-10 alignleft\" src=\"https:\/\/publicationsthema.files.wordpress.com\/2012\/08\/thema-logo-trasparente_small.png\" alt=\"THEMA - Logo TRASPARENTE_small\" width=\"51\" height=\"51\" \/><\/strong><\/p>\n<p><em><strong>Silvia Scarpellini<\/strong><strong><br \/>\n<\/strong>QA\/RA Manager<\/em><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Speaking of novelties and regulatory updates, we can certainly assert that the FDA never sleeps! Agency is always frenetically busy in  [&#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":[679,2],"tags":[],"class_list":["post-4751","post","type-post","status-publish","format-standard","hentry","category-blog-en","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>USA: wake up\u2026 FDA is speaking! - Thema Med<\/title>\n<meta name=\"description\" content=\"Speaking of novelties and regulatory updates, we can certainly assert that the FDA never sleeps! 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