{"id":7077,"date":"2023-10-16T16:40:44","date_gmt":"2023-10-16T16:40:44","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7077"},"modified":"2024-01-11T16:38:57","modified_gmt":"2024-01-11T16:38:57","slug":"fda-510k-process","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/fda-510k-process\/","title":{"rendered":"The FDA 510(k) Process: Setting the Stage for a Successful Submission and Faster Approval"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7077\" class=\"elementor elementor-7077\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1b0c5cde elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b0c5cde\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6dd05cd3\" data-id=\"6dd05cd3\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7ca59751 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"7ca59751\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-6ea4084d\" data-id=\"6ea4084d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3fab5c3f elementor-widget elementor-widget-post-info\" data-id=\"3fab5c3f\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2023\/10\/16\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tOctober 16, 2023\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f16c1c2 elementor-widget elementor-widget-heading\" data-id=\"5f16c1c2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">The FDA 510(k) Process: Setting the Stage for a Successful Submission and Faster Approval<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f7ff590 elementor-widget elementor-widget-image\" data-id=\"1f7ff590\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2639\" height=\"1760\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/Team-Planning-for-MDSAP.jpg\" class=\"attachment-full size-full wp-image-1588\" alt=\"MDSAP Planning\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/Team-Planning-for-MDSAP.jpg 2639w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/Team-Planning-for-MDSAP-300x200.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/Team-Planning-for-MDSAP-768x512.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/Team-Planning-for-MDSAP-1024x683.jpg 1024w\" sizes=\"(max-width: 2639px) 100vw, 2639px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1005398 elementor-widget elementor-widget-text-editor\" data-id=\"1005398\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>If you\u2019ve never prepared a medical device FDA premarket notification, commonly known as a 510(k) submission, figuring out where to begin can be daunting. The FDA website provides a goldmine of information but extracting those golden nuggets requires lots of digging. Fear not. This guide removes much of the confusion about the topic and after reading it you\u2019ll have a much better understanding of how the 510(k) process works.<\/p><p>\u00a0<\/p><p><strong>In this article:<\/strong><\/p><p><a href=\"#basic\"><u>Basic steps in the premarket notification process<\/u><\/a><\/p><p><a href=\"#confirm\"><u>Confirm that your medical device needs a 510(k)<\/u><\/a><\/p><p><a href=\"#identity\"><u>Identify the right product code and regulation number <\/u><\/a><\/p><p><a href=\"#choosing\"><u>Choosing the right predicate device <\/u><\/a><\/p><p><a href=\"#what\"><u>What if no predicate exists?<\/u><\/a><\/p><p><a href=\"#do\"><u>Do you have the data needed to support a submission?<\/u><\/a><\/p><p><a href=\"#fda\"><u>FDA 510(k) submission checklist<\/u><\/a><\/p><p><a href=\"#sifting\"><u>Sifting through guidance documents and standards<\/u><\/a><\/p><p><a href=\"#documents\"><span style=\"text-decoration: underline;\">Do We Have to Follow FDA Medical Device Guidance Documents?<\/span><\/a><\/p><p><a href=\"#application\"><u>What to expect after you submit your 510(k) application <\/u><\/a><\/p><p><a href=\"#sections\"><u>Sections of a 510(k) application<\/u><\/a><\/p><p><a href=\"#be\"><u>Be prepared for additional information (AI) requests <\/u><\/a><\/p><p><a href=\"#typical\"><u>Typical FDA 510(k) review cycle<\/u><\/a><\/p><p><a href=\"#why\"><u>Why 510(k) submissions get rejected <\/u><\/a><\/p><p><a href=\"#letter\"><u>FDA substantial equivalence letter<\/u><\/a><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0d21699 elementor-widget elementor-widget-menu-anchor\" data-id=\"0d21699\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\nbody.elementor-page .elementor-widget-menu-anchor{margin-bottom:0}<\/style>\t\t<div id=\"basic\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6006e54b elementor-widget elementor-widget-heading\" data-id=\"6006e54b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Basic Steps in the Medical Device Premarket Notification Process<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ce6da04 elementor-widget elementor-widget-text-editor\" data-id=\"2ce6da04\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>We\u2019ll explain various steps in the process throughout this guide, but let\u2019s start with a holistic review of the FDA approval process.<\/p><p>\u00a0<\/p><table width=\"765\"><tbody><tr><td width=\"31\"><p><strong>1<\/strong><\/p><\/td><td width=\"593\"><p>Confirm classification of your medical device and whether it falls under the 510(k) pathway.<\/p><\/td><\/tr><tr><td width=\"31\"><p><strong>2<\/strong><\/p><\/td><td width=\"593\"><p>Using the FDA website, identify the appropriate three-letter product code and regulation number for your device.<\/p><p>3. Determine whether your device can be submitted under a Traditional, Special or Abbreviated Pathway<\/p><\/td><\/tr><tr><td width=\"31\"><p><strong>3<\/strong><\/p><\/td><td width=\"593\"><p>Conduct research on the FDA database and select a predicate for comparison or if you will use recognized consensus standards and guidances to establish substantial equivalence.<\/p><\/td><\/tr><tr><td width=\"31\"><p><strong>4<\/strong><\/p><\/td><td width=\"593\"><p>Search on the FDA website for applicable FDA guidance documents.<\/p><\/td><\/tr><tr><td width=\"31\"><p><strong>5<\/strong><\/p><\/td><td width=\"593\"><p>Determine which international \u201cconsensus standards\u201d may apply to your device.<\/p><\/td><\/tr><tr><td width=\"31\"><p><strong>6<\/strong><\/p><\/td><td width=\"593\"><p>Identify clinical data and\/or testing that may be required for your device.<\/p><\/td><\/tr><tr><td width=\"31\"><p><strong>7<\/strong><\/p><\/td><td width=\"593\"><p>Complete performance testing and perform clinical studies (if required).<\/p><\/td><\/tr><tr><td width=\"31\"><p><strong>8<\/strong><\/p><\/td><td width=\"593\"><p>Assemble all documentation into the 510(k) application.<\/p><\/td><\/tr><tr><td width=\"31\"><p><strong>9<\/strong><\/p><\/td><td width=\"593\"><p>Review the Refuse to Accept (RTA) checklist to ensure that you\u2019re following the FDA guidelines for completeness.<\/p><\/td><\/tr><tr><td width=\"31\"><p><strong>10<\/strong><\/p><\/td><td width=\"593\"><p>Complete the User Fee Coversheet and pay the 510(k) review user fee and include the coversheet in the \u00a0510(k) submission to FDA.<\/p><\/td><\/tr><tr><td width=\"31\"><p><strong>11<\/strong><\/p><\/td><td width=\"593\"><p>Receive confirmation from FDA within 2 weeks that your 510(k) was accepted for substantive review.<\/p><\/td><\/tr><tr><td width=\"31\"><p><strong>12<\/strong><\/p><\/td><td width=\"593\"><p>If your 510(k) is determined to be substantially equivalent, you will receive a clearance letter that will be posted on the FDA website.\u00a0<\/p><p>Within 30 days of placing the device on the market, you must list it on the Device Registration Listing Module (DRLM) and pay the Device Listing Fee.<\/p><\/td><\/tr><\/tbody><\/table><p>The FDA will not issue a certificate or letter approving the new device.\u00a0 We should note that FDA does not technically \u201capprove\u201d devices via the 510(k) process \u2013 they \u201cclear\u201d (authorize) a device to be marketed in the US. That\u2019s why a 510(k) is called a\u00a0<em>premarket notification<\/em>\u00a0.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ad10559 elementor-widget elementor-widget-menu-anchor\" data-id=\"ad10559\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"confirm\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1af7ef elementor-widget elementor-widget-heading\" data-id=\"a1af7ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Confirm That Your Medical Device is Regulated by FDA and Needs a 510(k)<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb40341 elementor-widget elementor-widget-text-editor\" data-id=\"cb40341\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>This may seem obvious, but the very first step is to confirm that your product is a regulated medical device and needs to go through the 510(k) approval process. Some products (i.e., low-risk devices Class I products) do need to be registered with FDA but don\u2019t need to go through the FDA 510(k) process. Nearly all Class II devices must procure a 510(k). Following is information on how you can find out whether your device is regulated and needs a 510(k).<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5b431e5 elementor-widget elementor-widget-menu-anchor\" data-id=\"5b431e5\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"identity\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b42d2b2 elementor-widget elementor-widget-heading\" data-id=\"b42d2b2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Identify the Right Product Code and Regulation Number for Your Medical Device<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-81761d3 elementor-widget elementor-widget-text-editor\" data-id=\"81761d3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>FDA uses a risk-based predicate-based review approach. This means that when you submit your application to FDA, you will be comparing your medical device to a very similar device that has already been approved (the predicate) by FDA. Because FDA requires you to identify a single predicate device, your first step will be to find one. You may already have a good idea of which competitive products would make a suitable predicate for comparison in your 510(k). In any case, you should start your research using the\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPCD\/classification.cfm\">FDA Product Classification<\/a>\u00a0database.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-1359 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-classification-flowmeter.png\" alt=\"FDA screenshot - classification flowmeter\" width=\"922\" height=\"353\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-classification-flowmeter.png 922w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-classification-flowmeter-300x115.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-classification-flowmeter-768x294.png 768w\" sizes=\"(max-width: 922px) 100vw, 922px\" \/><\/p><p>For example, let\u2019s say your company is introducing a new cardiovascular blood flowmeter to the US market. The first step would be to begin with a simple device search on the FDA database, as shown, and then look at the options available. Start with broadest definition of your product \u2013 in this case, just the term \u201cflowmeter.\u201d The results show that there are six unique FDA product codes for products related to flowmeter.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-1361 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-search-results.png\" alt=\"FDA screenshot - search results\" width=\"1357\" height=\"342\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-search-results.png 1357w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-search-results-300x76.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-search-results-768x194.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-search-results-1024x258.png 1024w\" sizes=\"(max-width: 1357px) 100vw, 1357px\" \/><\/p><p>Code DPW looks to be the best match but, to make sure, click on the regulation number and carefully read the description.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-1362 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-870-2100.png\" alt=\"FDA screenshot - 870-2100\" width=\"1156\" height=\"567\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-870-2100.png 1156w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-870-2100-300x147.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-870-2100-768x377.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-870-2100-1024x502.png 1024w\" sizes=\"(max-width: 1156px) 100vw, 1156px\" \/><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-804b013 elementor-widget elementor-widget-menu-anchor\" data-id=\"804b013\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"choosing\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2772cd8 elementor-widget elementor-widget-heading\" data-id=\"2772cd8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Choosing the Right Predicate Device for Your 510(k) Submission<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-12ec9d5 elementor-widget elementor-widget-text-editor\" data-id=\"12ec9d5\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>After you have read the description associated with the regulation number and are absolutely certain that the product code DPW is the correct one that fits your device, then go the FDA\u2019s\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPMN\/pmn.cfm\">510(k) database<\/a>\u00a0and search for any devices cleared under product code DPW.<\/p><p>This is where things can get tricky and you need to be careful. In this example, there are 131 cleared medical devices under classification product code DPW. Which one will make the best predicate for your device? Well, here\u2019s a piece of advice: When reviewing your options (hopefully you will not have 131 options), it is best to sort by the \u201cDecision Date\u201d column and start with devices that were cleared recently. Why? While it may be tempting to choose an older device as your comparative predicate, the\u00a0<a href=\"https:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm626572.htm\">FDA frowns<\/a>\u00a0upon using devices cleared more than 10 years ago.<\/p><p>Your next step will be to click on the \u201cSummary\u201d link for each device as shown (see the example page below).<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-1363 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-K172457.png\" alt=\"FDA screenshot - K172457\" width=\"903\" height=\"632\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-K172457.png 903w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-K172457-300x210.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA-screenshot-K172457-768x538.png 768w\" sizes=\"(max-width: 903px) 100vw, 903px\" \/><\/p><p>Read these summaries very, very carefully. Pay attention to the intended use, allowed indications for use, testing conducted, and clinical studies that may have been performed. Some 510(k) summaries provide more information than others, so make sure you review as many as possible and aggregate your knowledge in a spreadsheet if you are reviewing a lot of summaries. Your chosen predicate does not need to be identical to your device, but it needs to be close enough not to raise additional safety and effectiveness questions. The chosen predicate must have the same intended use and indications for use. This is\u00a0<strong><em>very<\/em><\/strong>\u00a0important. If the indications for use are different, that device won\u2019t be a suitable predicate. The technological features should closely match your device. Choosing the right predicate is truly critical for the success of your submission and, if you have any reservations about your options, you should seek the advice of an experienced FDA consultant.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bf963db elementor-widget elementor-widget-menu-anchor\" data-id=\"bf963db\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"what\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1022d41 elementor-widget elementor-widget-heading\" data-id=\"1022d41\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What Happens If Your Device Is Truly Innovative and No Predicate Device Exists?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c7a0113 elementor-widget elementor-widget-text-editor\" data-id=\"c7a0113\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>A limitation of the FDA predicate registration system is that it does not easily accommodate innovation. In the past, this was why some companies introducing innovative technology chose to introduce their devices to the European market first. If you have truly new technology or your device combines two existing technologies, you can ask FDA to render an opinion on the classification and regulatory requirements for the device by submitting a\u00a0<a href=\"https:\/\/www.fda.gov\/downloads\/medicaldevices\/deviceregulationandguidance\/guidancedocuments\/ucm209851.pdf\">513(g) request for information<\/a>. Some companies making innovative low-risk medical devices without a suitable predicate device can go through the\u00a0<em>De Novo<\/em>\u00a0process. This allows FDA to assign a Class I or Class II designation and product code\/regulation number to a product that has no current relevant product code.<\/p><p>You may also request a\u00a0<a href=\"https:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM609753.pdf\">Q-Submission Meeting<\/a>\u00a0(Q Sub) with FDA to clarify regulatory requirements, get advice on what technical documentation to include, or discuss clinical studies needed to support your submission. These short meetings (in person, via phone, or in writing) allow you to ask a few substantive questions (depending on time allowed) and can be a worthwhile way to ensure that you don\u2019t waste time and money. Unless you are absolutely confident of the path you need to take and what will be required in your submission, we recommend taking advantage of a Q-Sub meeting. (We can help you with this.) Nearly two-thirds of all FDA 510(k) submissions are slowed down by Additional Information (AI) requests from FDA reviewers. We\u2019ll talk more about AI requests later.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c419eb8 elementor-widget elementor-widget-menu-anchor\" data-id=\"c419eb8\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"do\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8471c6c elementor-widget elementor-widget-heading\" data-id=\"8471c6c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Do You Have the Data Needed to Support a Successful FDA 510(k) Submission<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0644c8b elementor-widget elementor-widget-text-editor\" data-id=\"0644c8b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>So you\u2019ve done your homework and confirmed that your device must go through the 510(k) process. You know the classification, three-letter product code, and the regulation number, and you\u2019ve done an exhaustive review of summary documents for competing devices. You have chosen your predicate medical device and are ready proceed. Now what?<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e9011a1 elementor-widget elementor-widget-menu-anchor\" data-id=\"e9011a1\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"familiarize\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53cc89f elementor-widget elementor-widget-heading\" data-id=\"53cc89f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Familiarize Yourself with the FDA Submission Checklist<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9cfb0ca elementor-widget elementor-widget-text-editor\" data-id=\"9cfb0ca\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>If you have never seen a completed 510(k) before, you might be shocked to know that the average submission is nearly 1,200 pages. Many people vastly underestimate the work that goes into a submission, so it\u2019s probably not surprising that FDA reviewers initially reject about 30% of all submissions as being incomplete. Several years ago, FDA adopted a Refuse to Accept (RTA) policy to cut down on the time they were wasting reviewing woefully inadequate submissions from medical device companies. Now FDA uses a 50+ point review checklist before accepting any 510(k) for substantive review. You can read the FDA 510(k) acceptance criteria hereut provides great information, and you should study it carefully before starting your 510(k). 180 days to rectify the shortcomings and submit information against the deficiencies.<\/p><p>The next step in the process is determining which data is needed to support your submission. Generally, that supporting safety and efficacy data falls into four buckets.<\/p><p><strong>1<\/strong>\u00a0\u2013 Bench testing (performance, biocompatibility, electrical safety, sterilization, packaging, sterility, etc.<\/p><p><strong>2<\/strong>\u00a0\u2013 Clinical studies<\/p><p><strong>3<\/strong>\u00a0\u2013 Usability studies<\/p><p><strong>4<\/strong>\u00a0\u2013 Software validation and verification (if applicable)<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0e14eda elementor-widget elementor-widget-menu-anchor\" data-id=\"0e14eda\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"sifting\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e340280 elementor-widget elementor-widget-heading\" data-id=\"e340280\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Sifting Through Applicable Guidance Documents and International Standards<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4bb0492 elementor-widget elementor-widget-text-editor\" data-id=\"4bb0492\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>If you have done a good job of reading various 510(k) summaries for your competitors, you should already have an idea of what data may be required. Let\u2019s use the example of a cardiovascular blood flowmeter and focus on FDA guidance documents first. If you do a quick\u00a0<a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/default.htm\">search<\/a>\u00a0of FDA guidance documents and sort using \u201cMedical Devices\u201d and \u201cCardiovascular Devices,\u201d you will find no fewer than 21 guidance documents. Does your device include software? There are another eight guidance documents related to software and cybersecurity. Will all of these guidance documents apply to this cardiovascular blood flowmeter device? Absolutely not, but it is your unenviable job to read through them and determine which ones do apply. Again, if you have done a thorough job reviewing a lot of possible predicate devices, you\u2019ll likely see commonality in which specific testing was performed or standards followed.<\/p><p>It should be noted that in addition to the 700+ FDA medical device guidance documents, FDA also recommends the application of international \u201cconsensus standards\u201d in many cases. One common example is the IEC 60601 series of electrical safety standards, and the ISO 14971 standard for risk management. The IEC 60601-1 series of standards is for general safety and performance, while the IEC 60601-2-x series applies to specific medical equipment.<\/p><p>Again, as you review possible predicate devices and read their 510(k) summary documents posted on the FDA website, you will discover that many companies disclose the specific testing that was conducted on their product. For example, with regard to the cardiovascular blood flowmeter mentioned earlier, one manufacturer listed the tests performed on their device in their 510(k) summary:<\/p><ul><li>Electrical safety testing<\/li><li>Battery testing<\/li><li>EMC testing<\/li><li>Software validation<\/li><li>Shock\/vibration testing<\/li><li>Mechanical validation<\/li><li>Packaging testing<\/li><\/ul><p>Of course, there are many companies that specialize in performing medical device testing, and you will also want to confer with them and triangulate which specific testing will be needed for your device. Just keep in mind that their job is to sell testing. Trust but verify\u2026.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f36e339 elementor-widget elementor-widget-menu-anchor\" data-id=\"f36e339\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"documents\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-50efdcc elementor-widget elementor-widget-heading\" data-id=\"50efdcc\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Do We Have to Follow FDA Medical Device Guidance Documents?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b5fd5b4 elementor-widget elementor-widget-text-editor\" data-id=\"b5fd5b4\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Technically no, but guidance documents reflect current FDA thinking on a topic, so you would be foolish to ignore them.\u00a0 However, be prepared to substantiate with a scientifically justified alternative for any deviations from the published guidance or else you will receive a request for Additional Information (AI) during the review of the 510k. In fact, during the RTA checklist review, FDA reviewers will often cite specific references to guidance documents if the company has not applied them. You will run across many \u201cdraft\u201d guidance documents in the FDA database, some going as far back as 2007. The word\u00a0<em>draft\u00a0<\/em>is a bit of a misnomer, because people erroneously assume these draft documents are not yet being applied by FDA. However, draft guidance documents are really early versions of guidance documents about which the FDA is still accepting industry feedback. Guidance documents often remain in draft format for many years but are applied during this time.<\/p><p>Keep in mind that FDA does also withdraw guidance documents, so when you are reviewing 510(k) summaries for predicate devices or doing other research and you see specific guidance mentioned, make sure the guidance in question is still in effect. Here\u2019s a\u00a0<a href=\"https:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm425025.htm\">list<\/a>\u00a0of withdrawn CDRH guidance documents.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-195a360 elementor-widget elementor-widget-menu-anchor\" data-id=\"195a360\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"application\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-285251f elementor-widget elementor-widget-heading\" data-id=\"285251f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What to Expect After You Submit Your 510(k) Application to FDA<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-904e89b elementor-widget elementor-widget-text-editor\" data-id=\"904e89b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>FDA does not publish a specific template for the 510(k) application, but they do want you to organize your submission into 20 specific sections. Sections 14-20 may not be applicable, depending on your device. While there is no specific template to follow, FDA does provide a thorough overview of what is expected in each section\u00a0know more\u00a0\u2013 you should start by reading this page, as it contains links to numerous other guidance documents that pertain to each section.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c6b4b3d elementor-widget elementor-widget-menu-anchor\" data-id=\"c6b4b3d\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"sections\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0cec96c elementor-widget elementor-widget-heading\" data-id=\"0cec96c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Sections of a 510(k) Application<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5a3b11a elementor-widget elementor-widget-text-editor\" data-id=\"5a3b11a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<table width=\"765\"><tbody><tr><td width=\"30\"><p><strong>1<\/strong><\/p><\/td><td width=\"302\"><p>Medical Device User Fee Cover Sheet (Form FDA 3601)<\/p><\/td><\/tr><tr><td><p><strong>2<\/strong><\/p><\/td><td><p>CDRH Premarket Review Submission Cover Sheet<\/p><\/td><\/tr><tr><td><p><strong>3<\/strong><\/p><\/td><td><p>510(k) Cover Letter<\/p><\/td><\/tr><tr><td><p><strong>4<\/strong><\/p><\/td><td><p>Indications for Use Statement<\/p><\/td><\/tr><tr><td><p><strong>5<\/strong><\/p><\/td><td><p>510(k) Summary or 510(k) Statement<\/p><\/td><\/tr><tr><td><p><strong>6<\/strong><\/p><\/td><td><p>Truthful and Accuracy Statement<\/p><\/td><\/tr><tr><td><p><strong>7<\/strong><\/p><\/td><td><p>Class III Summary and Certification<\/p><\/td><\/tr><tr><td><p><strong>8<\/strong><\/p><\/td><td><p>Financial Certification or Disclosure Statement<\/p><\/td><\/tr><tr><td><p><strong>9<\/strong><\/p><\/td><td><p>Declarations of Conformity and Summary Reports<\/p><\/td><\/tr><tr><td><p><strong>10<\/strong><\/p><\/td><td><p>Executive Summary<\/p><\/td><\/tr><tr><td><p><strong>11<\/strong><\/p><\/td><td><p>Device Description<\/p><\/td><\/tr><tr><td><p><strong>12<\/strong><\/p><\/td><td><p>Substantial Equivalence Discussion<\/p><\/td><\/tr><tr><td><p><strong>13<\/strong><\/p><\/td><td><p>Proposed Labeling<\/p><\/td><\/tr><tr><td><p><strong>14<\/strong><\/p><\/td><td><p>Sterilization and Shelf Life<\/p><\/td><\/tr><tr><td><p><strong>15<\/strong><\/p><\/td><td><p>Biocompatibility<\/p><\/td><\/tr><tr><td><p><strong>16<\/strong><\/p><\/td><td><p>Software<\/p><\/td><\/tr><tr><td><p><strong>17<\/strong><\/p><\/td><td><p>Electromagnetic Compatibility and Electrical Safety<\/p><\/td><\/tr><tr><td><p><strong>18<\/strong><\/p><\/td><td><p>Performance Testing\u2014Bench<\/p><\/td><\/tr><tr><td><p><strong>19<\/strong><\/p><\/td><td><p>Performance Testing\u2014Animal<\/p><\/td><\/tr><tr><td><p><strong>20<\/strong><\/p><\/td><td><p>Performance Testing\u2014Clinical<\/p><\/td><\/tr><\/tbody><\/table><p>As we mentioned before, the average 510(k) submission is 1,200 pages long! These days FDA reviewers spend about twice as much time reviewing each submission as they did 15 years ago, and much of that increased scrutiny is directed at specific testing and clinical results found in sections 14-20. Also, in the past FDA might have assigned one reviewer to a 510(k) but today several reviewers are involved, including specialists in biocompatibility, electrical safety, and risk management.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0daf62 elementor-widget elementor-widget-menu-anchor\" data-id=\"c0daf62\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"be\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f4a850d elementor-widget elementor-widget-heading\" data-id=\"f4a850d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Be Prepared: Additional Information (AI) Requests Are Common<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a250752 elementor-widget elementor-widget-text-editor\" data-id=\"a250752\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>When you submit your 510(k) to FDA, the first hurdle is to have it accepted for substantive review. If your submission does not pass FDA\u2019s 50+ point checklist, they will kick it back to you. You certainly don\u2019t want that to happen when you\u2019ve spent months preparing your 510(k), double-checking all details, and following all FDA guidance documents.<\/p><p>Theoretically, in less than three months you should have a clearance letter from FDA in hand and a pat on the back from your boss. But don\u2019t uncork the champagne just yet \u2013 nearly two-thirds of all premarket notification submissions receive an ego-deflating Additional Information (AI) request from FDA. For minor issues, this could take the form of a simple phone call from the FDA reviewer (Interactive Review), but for more substantial questions an AI letter will be issued. Common issues that spur an AI request include:<\/p><p>\u00a0<\/p><ul><li>Inadequate device description or discrepancies throughout the application.<\/li><li>Discrepancies or problems related to indications for use (e.g., your indications don\u2019t match throughout the submission).<\/li><li>Failure to follow published guidance or standards.<\/li><li>Missing performance testing or clinical data (rookie mistake: submitting summaries and not full testing reports and protocols).<\/li><li>Skipped sections. Perhaps your device does not have biocompatibility issues, but you can\u2019t just say \u201cnot applicable\u201d and move on \u2013 you need to acknowledge the requirement and say why your device does not require biocompatibility testing.<\/li><\/ul><p>Also, despite the bounty of information published by FDA, sometimes a reviewer asks for information that may not have been published in any FDA guidance document or standard. This does happen and, if it happens to your submission, you will need to deal with it. If an AI request is submitted to your firm, your submission is placed on hold for up to 180 days (just as with the RTA discussed above). If you are unable to supply the requested information within that timeframe, your 510(k) submission may be withdrawn or cancelled, which means you will need to submit again\u2026and pay the review fee again. That\u2019s not a discussion you want to have with your boss during your weekly update.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e8e5c35 elementor-widget elementor-widget-menu-anchor\" data-id=\"e8e5c35\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"typical\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b46e6dc elementor-widget elementor-widget-heading\" data-id=\"b46e6dc\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Typical FDA 510(k) Review Cycle (Calendar Days)<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f54d0a3 elementor-widget elementor-widget-text-editor\" data-id=\"f54d0a3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Plan on six months from the hopeful day you submit until the joyous occasion when you are holding that \u201csubstantial equivalence\u201d letter in your hand. In all fairness, because such a high percentage of companies receive additional information requests from FDA, the amount of total time that FDA spends reviewing your submission is only slightly longer than the amount of time companies spend replying to FDA requests. The average time to clearance is around five or six months but that also varies by device.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-1602 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA_510k_review.png\" alt=\"FDA_510k_review\" width=\"1175\" height=\"254\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA_510k_review.png 1175w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA_510k_review-300x65.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA_510k_review-768x166.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/FDA_510k_review-1024x221.png 1024w\" sizes=\"(max-width: 1175px) 100vw, 1175px\" \/><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6c10173 elementor-widget elementor-widget-menu-anchor\" data-id=\"6c10173\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"why\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e98e41 elementor-widget elementor-widget-heading\" data-id=\"5e98e41\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why 510(k) Submissions Get Rejected as NSE<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dfb17e0 elementor-widget elementor-widget-text-editor\" data-id=\"dfb17e0\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>It can be the most soul-crushing letter any regulatory professional could receive: the dreaded not substantially equivalent (NSE) letter from FDA. While thousands of submissions get blessed by FDA each year, hundreds don\u2019t make the cut. Even if devices accepted for substantive FDA review and their sponsors reply to AI requests, some of the applications get rejected. Why? Typically, an NSE letter is issued because no matching predicate exists, the device has a different intended use, the device has different technological characteristics, or performance testing does not support safety and efficacy of the device. If a device is rejected because no predicate exists, companies may be able to request a risk-based classification from FDA via a\u00a0<em>De Novo<\/em>\u00a0petition.<\/p><p>In addition to the applications that are rejected, hundreds more are abandoned (withdrawn) because the sponsor of the 510(k) could not produce the necessary testing or data requested in the AI letter.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-805ea61 elementor-widget elementor-widget-menu-anchor\" data-id=\"805ea61\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"letter\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e69b47 elementor-widget elementor-widget-heading\" data-id=\"3e69b47\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Your Device Is Substantially Equivalent: The FDA Letter Every Company Wants to Receive<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-157e528 elementor-widget elementor-widget-text-editor\" data-id=\"157e528\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Luckily most companies do not get NSE letters. The substantially equivalent (SE) letter is not an approval by FDA, but it serves the same purpose because it legally authorizes the holder to market the device in the US. Unlike other countries, no certificate will be issued by FDA but your SE letter will be posted on the FDA website along with your 510(k) summary. Your 510(k) clearance will not expire and is valid until you make changes to the intended use, alter the indications for use, or change technological characteristics. At the time your 510(k) clearance letter is issued, you are expected to be in full compliance with the FDA Quality System Regulation (21 CFR Part 820) when distribution of the device begins in the US.<\/p><p>Getting FDA clearance for a medical device is a lot of work and a huge accomplishment. If you spend time doing your homework, you can be assured that your path to 510(k) success will be shorter, smoother, and more likely to result in you securing the coveted substantially equivalent letter.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d525a12 elementor-widget elementor-widget-heading\" data-id=\"d525a12\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Want to Learn More About Preparing a 510(k) Application?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a2510d2 elementor-widget elementor-widget-text-editor\" data-id=\"a2510d2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>We hope you have enjoyed this guide to the FDA 510(k) process. If you are getting ready to start your first 510(k), consider our\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/FDA-510k-CE-Mark-medial-device-training\">training class<\/a>\u00a0on FDA and European regulatory submissions. Also, our team of FDA experts is available to help you with\u00a0<a href=\"https:\/\/www.orielstat.com\/practice\/FDA-510k-submissions-consulting\">510(k) strategy, review, or compilation<\/a>.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-375d07a3 elementor-widget elementor-widget-shortcode\" data-id=\"375d07a3\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-shortcode\"><div class=\"container\">\n    <div class=\"col-lg-12 col-md-12\">\n        <h5 class=\"elementor-heading-title elementor-size-default\">Our team is here to help. <a href=\"javascript:void(0);\" rel=\"nofollow\" noindex=\"noindex\">Contact us online<\/a><\/h5>\n        <h5 class=\"elementor-heading-title elementor-size-default\">or<\/h5>\n        <h6 class=\"elementor-heading-title elementor-size-default\">Get answers right now. 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a Successful Submission and Faster Approval If you\u2019ve never prepared a medical device FDA premarket notification, commonly known as a 510(k) submission, figuring out where to begin can be daunting. The FDA website provides a goldmine of information but extracting those golden nuggets requires lots of digging. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1588,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[14,21],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/fda-510k-process\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"The FDA 510(k) Process: Setting the Stage for a Successful Submission and Faster Approval If you\u2019ve never prepared a medical device FDA premarket notification, commonly known as a 510(k) submission, figuring out where to begin can be daunting. The FDA website provides a goldmine of information but extracting those golden nuggets requires lots of digging. 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The FDA website provides a goldmine of information but extracting those golden nuggets requires lots of digging. 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