{"id":217,"date":"2023-06-29T11:33:00","date_gmt":"2023-06-29T16:33:00","guid":{"rendered":"https:\/\/www.rqmplus.com\/?post_type=scb-resources&#038;p=217"},"modified":"2025-06-05T15:52:05","modified_gmt":"2025-06-05T20:52:05","slug":"pre-submission-to-preeminence-showcasing-fdas-latest-pre-sub-guidance-and-uncovering-pccp-best-practices","status":"publish","type":"scb-resources","link":"https:\/\/www.rqmplus.com\/resources\/pre-submission-to-preeminence-showcasing-fdas-latest-pre-sub-guidance-and-uncovering-pccp-best-practices\/","title":{"rendered":"Pre-Submission to Preeminence: Showcasing FDA&#8217;s Latest Pre-Sub Guidance and Uncovering PCCP Best Practices"},"content":{"rendered":"\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" width=\"960\" height=\"540\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/RQM_Live_68_Promo_On_Demand.webp\" alt=\"recorded 29 June 2023 pre-submission to preeminence showcasing FDA's latest pre-submission guidance and uncovering pccp best practices\" class=\"wp-image-263\" style=\"width:550px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/RQM_Live_68_Promo_On_Demand.webp 960w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/RQM_Live_68_Promo_On_Demand-300x169.webp 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2024\/05\/RQM_Live_68_Promo_On_Demand-768x432.webp 768w\" sizes=\"(max-width: 960px) 100vw, 960px\" \/><\/figure>\n\n\n\n<p>This panel discussion was all about the FDA&#8217;s latest pre-submission guidance, with an emphasis on best practices for Predetermined Change Control Plans (PCCP). As always, we took questions from the audience and answered as many as we could!&nbsp;<\/p>\n\n\n\n<p>Key points of discussion included:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Unveiling FDA&#8217;s new pre-submission guidance and its implications\u00a0<\/li>\n\n\n\n<li>Pros and cons of implementing pre-submission meetings for regulatory success<\/li>\n\n\n\n<li>Leveraging pre-submission meetings for QSR follow-ups and risk mitigation<\/li>\n\n\n\n<li>A thorough exploration of PCCP (beyond just software); some specifics include:\n<ul class=\"wp-block-list\">\n<li>Applicable to PMA and 510(k) devices (previously not available for 510k devices unless the predicate had one)<\/li>\n\n\n\n<li>Includes labeling for the proposed change and performance requirements for changes made under the plan<\/li>\n\n\n\n<li>Allows manufacturers to make pre-planned changes without a new submission<\/li>\n\n\n\n<li>If choosing a predicate, it must be what was reviewed by FDA and not the device version that underwent a change control plan<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Understanding the 2022 Omnibus Appropriations Bill: Streamlining PCCP submissions<\/li>\n\n\n\n<li>How RQM+ empowers clients with comprehensive support in this area, from package preparation to remediation\u00a0<\/li>\n<\/ul>\n\n\n\n<p>Don&#8217;t miss this opportunity to explore the advantages, potential challenges, and optimal approaches to leverage pre-submission meetings and PCCPs. We hope you\u2019ll join our experienced and versatile team as they explore these topics and answer your questions.&nbsp;&nbsp;<\/p>\n\n\n\n<p>Complete the form to watch on demand!&nbsp;<\/p>\n\n\n\n<p>Panelists:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Nancy Morrison, RAC \u2013 Vice President, Intelligence &amp; Innovation<\/li>\n\n\n\n<li>Allison Komiyama, Ph.D., RAC \u2013 Vice President, MedTech Innovation<\/li>\n\n\n\n<li>Hrishikesh Gadagkar \u2013 Principal Engineer<\/li>\n\n\n\n<li>Bryan Pinder, RAC \u2013 Principal Engineer (former FDA CDRH Lead Reviewer)<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>This panel discussion was all about the FDA&#8217;s latest pre-submission guidance, with an emphasis on best practices for Predetermined Change&#8230;<\/p>\n","protected":false},"author":2,"featured_media":157,"template":"","meta":{"_acf_changed":false,"_links_to":"","_links_to_target":""},"resource-type":[6],"topic":[9],"class_list":["post-217","scb-resources","type-scb-resources","status-publish","has-post-thumbnail","hentry","resource-type-rqm-live","topic-regulatory-quality"],"acf":[],"card_info":{"title":"Pre-Submission to Preeminence: Showcasing FDA&#8217;s Latest Pre-Sub Guidance and Uncovering PCCP Best Practices","link":"https:\/\/www.rqmplus.com\/resources\/pre-submission-to-preeminence-showcasing-fdas-latest-pre-sub-guidance-and-uncovering-pccp-best-practices\/","link_target":"_self","name":"RQM+ Live!","slug":"rqm-live","thumbnail":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/01\/AdobeStock_334138696.jpg","excerpt":"This panel discussion was all about the FDA&#8217;s latest pre-submission guidance, with an emphasis on best practices for Predetermined Change...","display_date":"June 29, 2023"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA&#039;s New Pre-Sub Guidance and PCCP Best Practices | RQM+<\/title>\n<meta name=\"description\" content=\"Watch our on-demand panel discussion to explore the FDA&#039;s latest pre-submission guidance, the benefits of pre-submission meetings, and best practices for implementing Predetermined Change Control Plans (PCCP).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.rqmplus.com\/resources\/pre-submission-to-preeminence-showcasing-fdas-latest-pre-sub-guidance-and-uncovering-pccp-best-practices\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA&#039;s New Pre-Sub Guidance and PCCP Best Practices | RQM+\" \/>\n<meta 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