{"id":9912,"date":"2019-06-28T14:07:04","date_gmt":"2019-06-28T12:07:04","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=9912"},"modified":"2023-01-24T15:02:05","modified_gmt":"2023-01-24T14:02:05","slug":"laser-product-safety-fda-attempts-to-align-us-regulatory-requirements-with-international-consensus-standards","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2019\/06\/28\/laser-product-safety-fda-attempts-to-align-us-regulatory-requirements-with-international-consensus-standards\/","title":{"rendered":"Laser product safety: FDA attempts to align US regulatory requirements with international consensus standards"},"content":{"rendered":"\n<p>On May 8, 2019 FDA has finalized its guidance on the regulatory requirements applicable to laser products entitled \u201c<em><a rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\" href=\"https:\/\/www.fda.gov\/media\/110120\/download\" target=\"_blank\">Final guidance &#8211; Laser Products &#8211; Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)<\/a> <\/em>\u201d.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/06\/USA_laser_standards-1024x536.png\" alt=\"\" class=\"wp-image-9907\"\/><figcaption><em>Laser product safety: FDA attempts to align US regulatory requirements with international consensus standards<\/em><br><\/figcaption><\/figure>\n\n\n\n<p>FDA has set in place their own radiation safety\nproduct performance standards (21 CFR 1040.10 and 1040.11) that must be met by\nmanufacturers in order for laser products to be legally placed on the U.S.\nmarket. Therefore, devices sold on the U.S. market as well as other countries may\nhave to comply with international consensus standards IEC standards <strong>and<\/strong> FDA\nregulatory requirements. <\/p>\n\n\n\n<p>Major stakeholders such as Laser Illuminated\nProjector Association (LIPA) and flow cytometry IVD systems manufacturer Beckman\nCoulter, insisted for changes in the FDA\u2019s proposed guidance asking for <strong>full\nharmonization<\/strong> with the IEC standards, claiming that such changes would have\na noteworthy impact on the certification efforts and costs.<\/p>\n\n\n\n<p>Despite major changes brought to the document\u2019s\ntext after FDA received the industry\u2019s feedback, the final guidance falls short\nof full harmonization with IEC standards <strong>60825-1<\/strong>: <em>Safety of laser\nproducts &#8211; Part 1: Equipment classification, and requirements<\/em>, Edition 3.0 and\n<strong>60601-2-22<\/strong>: <em>Medical electrical equipment &#8211; Part 2-22: Particular\nrequirements for basic safety and essential performance of surgical, cosmetic,\ntherapeutic and diagnostic laser equipment<\/em>, Edition. 3.1.<\/p>\n\n\n\n<p>This\nguidance replaces the \u201c<em>Immediately in Effect Guidance Document:\nClassification and Requirements for Laser Illuminated Projectors (LIPs)<\/em>\u201d issued\non February 18, 2015.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On May 8, 2019 FDA has finalized its guidance on the regulatory requirements applicable to laser products entitled \u201cFinal guidance &#8211;  [&#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-9912","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>Laser product safety: FDA attempts to align US regulatory requirements with international consensus standards - 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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