{"id":4216,"date":"2026-05-18T08:30:29","date_gmt":"2026-05-18T15:30:29","guid":{"rendered":"https:\/\/drugtestsinbulk.com\/blog\/?p=4216"},"modified":"2026-05-18T04:39:17","modified_gmt":"2026-05-18T11:39:17","slug":"fda-cleared-vs-approved-test-kits","status":"publish","type":"post","link":"https:\/\/drugtestsinbulk.com\/blog\/fda-cleared-vs-approved-test-kits\/","title":{"rendered":"FDA Cleared vs Approved: Know Before You Purchase Test Kits"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">FDA Cleared vs Approved is one of the most misunderstood topics when buying drug test kits, medical devices, and screening products. Many buyers assume the terms mean the same thing, but they represent different FDA review pathways. Knowing the distinction helps businesses choose reliable products, avoid misleading claims, and purchase test kits that meet workplace or compliance needs.<\/span><\/p>\n<h2><b>Quick Summary<\/b><\/h2>\n<ul>\n<li><a style=\"color: #4d9cbe;\" href=\"#section1\">FDA Cleared vs Approved: What These Terms Mean<\/a><\/li>\n<li><a style=\"color: #4d9cbe;\" href=\"#section2\">Difference Between FDA Cleared and Approved<\/a><\/li>\n<li><a style=\"color: #4d9cbe;\" href=\"#section3\">FDA Cleared vs Approved Products List: Where Drug Test Kits Fit<\/a><\/li>\n<li><a style=\"color: #4d9cbe;\" href=\"#section4\">What to Look for Beyond FDA Cleared vs Approved Status in Test Kits<\/a><\/li>\n<li><a style=\"color: #4d9cbe;\" href=\"#section5\">FDA-Cleared Drug Test Kits for Businesses<\/a><\/li>\n<li><a style=\"color: #4d9cbe;\" href=\"#section6\">FDA Cleared vs Approved: Key Takeaways for Test Kit Buyers<\/a><\/li>\n<\/ul>\n<h2 id=\"section1\"><b>FDA Cleared vs Approved: What These Terms Mean<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">The FDA uses different review pathways depending on the type of medical device, its intended use, and its level of risk. Most rapid drug test kits are classified as medical devices and generally fall under the FDA clearance process rather than the FDA approval process.<\/span><\/p>\n<h3><b>What Does \u201cCleared by the FDA\u201d Mean?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">A product is FDA cleared when the manufacturer submits a 510(k) premarket notification and demonstrates that the device is <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/premarket-notification-510k\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">substantially equivalent<\/span><\/a><span style=\"font-weight: 400;\"> to another legally marketed device. Most moderate-risk medical devices, including many diagnostic and drug-testing kits, use this pathway because it is faster and is designed for products similar to existing technologies. <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/device-approvals-denials-and-clearances\/510k-clearances\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">FDA clearance<\/span><\/a><span style=\"font-weight: 400;\"> does not mean the product skipped testing; manufacturers still need to provide safety, performance, and validation data.<\/span><\/p>\n<h3><b>What Does \u201cFDA Approved\u201d Mean?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">A product is FDA-approved when it undergoes the <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/device-approvals-denials-and-clearances\/pma-approvals\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Premarket Approval (PMA)<\/span><\/a><span style=\"font-weight: 400;\"> process. PMA is the FDA\u2019s most rigorous review pathway and typically applies to high-risk Class III medical devices, such as implantable pacemakers and life-supporting devices. FDA approval requires extensive scientific evidence, often including clinical studies, to demonstrate that the product is safe and effective for its intended use.<\/span><\/p>\n<h2 id=\"section2\"><b>Difference Between FDA Cleared and Approved<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">The difference between FDA-cleared and approved products comes down to regulatory pathway, risk classification, and intended use.\u00a0<\/span><\/p>\n<h3><b>FDA Regulatory Pathways Explained<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">The FDA uses several pathways to authorize medical devices:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>510(k) Clearance<\/b><span style=\"font-weight: 400;\"> \u2013 For devices substantially equivalent to existing products<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Premarket Approval (PMA)<\/b><span style=\"font-weight: 400;\"> \u2013 For high-risk products requiring extensive clinical evidence<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>De Novo Classification<\/b><span style=\"font-weight: 400;\"> \u2013 For new, low-to-moderate-risk products without a predicate device<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Most drug tests, such as <\/span><a href=\"https:\/\/drugtestsinbulk.com\/drug-tests\/urine-cup.html\"><span style=\"font-weight: 400;\">urine cups<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/drugtestsinbulk.com\/drug-tests\/urine-dip.html\"><span style=\"font-weight: 400;\">dip cards<\/span><\/a><span style=\"font-weight: 400;\">, and <\/span><a href=\"https:\/\/drugtestsinbulk.com\/drug-tests\/saliva-oral.html\"><span style=\"font-weight: 400;\">oral fluid tests<\/span><\/a><span style=\"font-weight: 400;\">, are regulated under the 510(k) pathway.<\/span><\/p>\n<h3><b>Risk Classification and Intended Use<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Medical devices are categorized by risk:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Class I:<\/b><span style=\"font-weight: 400;\"> Low risk.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Class II:<\/b><span style=\"font-weight: 400;\"> Moderate risk.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Class III:<\/b><span style=\"font-weight: 400;\"> High risk.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Most drug test kits are Class II devices, meaning they require clearance but not full approval. Their intended use, screening rather than diagnosis, also influences this classification.<\/span><\/p>\n<h3><b>Accuracy, Testing Standards, and Validation<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Both FDA-cleared and FDA-approved products must meet strict quality and manufacturing standards. However, approved devices often require more extensive clinical evidence.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For drug testing kits, manufacturers typically submit:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sensitivity and specificity data<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">False-positive and false-negative rates<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Stability and shelf-life studies<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Usability and labeling information<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The FDA evaluates whether the product performs consistently and safely for its intended purpose.<\/span><\/p>\n<h2 id=\"section3\"><b>FDA Cleared vs Approved Products List: Where Drug Test Kits Fit<\/b><\/h2>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-4218 size-large\" src=\"https:\/\/drugtestsinbulk.com\/blog\/wp-content\/uploads\/2026\/05\/lab-doctor-performing-medical-exam-urine-510x340.jpg\" alt=\"FDA cleared vs approved: Urine drug test kit with specimen cup and detection strips\" width=\"510\" height=\"340\" srcset=\"https:\/\/drugtestsinbulk.com\/blog\/wp-content\/uploads\/2026\/05\/lab-doctor-performing-medical-exam-urine-510x340.jpg 510w, https:\/\/drugtestsinbulk.com\/blog\/wp-content\/uploads\/2026\/05\/lab-doctor-performing-medical-exam-urine-480x320.jpg 480w\" sizes=\"auto, (min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) 510px, 100vw\" \/><\/p>\n<p><span style=\"font-weight: 400;\">Many consumers can compare FDA-cleared vs. FDA-approved products from official lists. Drug testing kits usually appear on the FDA-cleared list.<\/span><\/p>\n<h3><b>Why Most Drug Testing Kits Are FDA Cleared (510k)<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Most drug testing kits are FDA-cleared through the 510(k) pathway because they are considered substantially equivalent to previously marketed diagnostic devices, a distinction that is especially important when evaluating<\/span> <a href=\"https:\/\/drugtestsinbulk.com\/blog\/510k-clearance-vs-approval-drug-test-kits\/\"><span style=\"font-weight: 400;\">510(k) clearance vs approval for drug test kits<\/span><\/a><span style=\"font-weight: 400;\">. This pathway allows manufacturers to demonstrate comparable safety and performance without undergoing the lengthy PMA approval process.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Urine and saliva drug tests, as well as rapid multi-panel screening kits, commonly use this regulatory route.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA-cleared products are still reviewed carefully and must comply with FDA Quality System requirements, labeling rules, and post-market obligations.<\/span><\/p>\n<h3><b>Are There FDA-Approved Drug Test Kits?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">While some high-risk medical devices undergo FDA approval through the PMA process, workplace drug test cups, dip cards, and oral fluid drug tests are almost always FDA-cleared rather than FDA-approved.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">This distinction is often confusing because some marketers incorrectly use the term \u201cFDA approved\u201d to describe 510(k)-cleared products. The FDA specifically differentiates these terms, and they should not be used interchangeably.<\/span><\/p>\n<h2 id=\"section4\"><b>What to Look for Beyond FDA Cleared vs Approved Status in Test Kits<\/b><\/h2>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-4062 size-large\" src=\"https:\/\/drugtestsinbulk.com\/blog\/wp-content\/uploads\/2026\/04\/saliva-test-510x340.jpg\" alt=\"FDA cleared vs approved - professional collecting an oral swab sample\" width=\"510\" height=\"340\" srcset=\"https:\/\/drugtestsinbulk.com\/blog\/wp-content\/uploads\/2026\/04\/saliva-test-510x340.jpg 510w, https:\/\/drugtestsinbulk.com\/blog\/wp-content\/uploads\/2026\/04\/saliva-test-480x320.jpg 480w\" sizes=\"auto, (min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) 510px, 100vw\" \/><\/p>\n<p><span style=\"font-weight: 400;\">Regulatory status is important, but it is only one part of the purchasing decision. When evaluating drug testing kits, employers and healthcare providers should also consider the following factors.<\/span><\/p>\n<ul>\n<li>\n<h3><b>Detection panel (5-panel, 10-panel, 12-panel, etc.)<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Different panels detect different substances. Choose based on your workplace or regulatory requirements. DrugTests<strong>InBulk<\/strong> (DTIB) offers multiple configurations, including <\/span><a href=\"https:\/\/drugtestsinbulk.com\/five-panel-prescreen-plus-cup-clia-waived.html\"><span style=\"font-weight: 400;\">PreScreen Plus 5 Panel Drug Test Cup<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/drugtestsinbulk.com\/ten-panel-clear-scan-drug-test-cup-csc-4104.html\"><span style=\"font-weight: 400;\">Ten-Panel Clear Scan Drug Test Cup<\/span><\/a><span style=\"font-weight: 400;\">, and <\/span><a href=\"https:\/\/drugtestsinbulk.com\/twelve-panel-cup-clia-waived-adulterants-hcdoaew-6125a3-2.html\"><span style=\"font-weight: 400;\">12-Panel Insight Drug Test Cup<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/li>\n<li>\n<h3><b>CLIA-waived status if needed<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">If testing outside a traditional lab, <\/span><a href=\"https:\/\/drugtestsinbulk.com\/drug-tests\/clia-waived.html\"><span style=\"font-weight: 400;\">CLIA-waived products<\/span><\/a><span style=\"font-weight: 400;\"> may be important, depending on the use setting and applicable regulations.<\/span><\/li>\n<li>\n<h3><b>Cutoff levels and confirmation compatibility<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Make sure cutoff thresholds align with workplace policy. Also, confirm whether non-negative results can be sent for lab confirmation.<\/span><\/li>\n<li>\n<h3><b>Shelf life and storage conditions<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Longer shelf life reduces waste. Stable storage requirements help buyers in warm or variable climates.<\/span><\/li>\n<li>\n<h3><b>Result speed<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Rapid read times support efficient onboarding and workplace screening.<\/span><\/li>\n<li>\n<h3><b>Tamper-evident design<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Built-in temperature strips, secure lids, and tamper checks can strengthen chain-of-custody practices.<\/span><\/li>\n<li>\n<h3><b>Bulk pricing for employers<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Large employers and clinics should compare case pricing, subscription ordering, and reorder flexibility when purchasing testing supplies in bulk. DrugTests<strong>InBulk<\/strong> (DTIB) provides competitive prices for bulk orders and free shipping.<\/span><\/li>\n<li>\n<h3><b>Supplier reputation and support<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Strong customer service, clear documentation, and reliable shipping are just as valuable as price. Employers often rely on suppliers like DrugTests<strong>InBulk<\/strong> (DTIB) for consistent support and product availability.<\/span><\/li>\n<\/ul>\n<h2 id=\"section5\"><b>FDA-Cleared Drug Test Kits for Businesses<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Businesses, clinics, and occupational health providers commonly use FDA-cleared test kits for pre-employment, random, post-accident, and reasonable suspicion screening.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">These products offer fast turnaround times and reduce costs compared to laboratory-only testing workflows.<\/span><\/p>\n<h3><b>Where to Buy FDA-Cleared Drug Test Kits<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Employers seeking dependable workplace testing supplies can purchase FDA-cleared products from<\/span><a href=\"https:\/\/drugtestsinbulk.com\/\"> <span style=\"font-weight: 400;\">DrugTests<strong>InBulk<\/strong><\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Drug Tests in Bulk specializes in professional-grade urine drug test cups, saliva drug tests, and multi-panel kits designed for workplace and clinical use.<\/span><\/p>\n<div class=\"product-container\">\n<div class=\"product-box\">\n<p style=\"text-align: center;\"><a style=\"color: #4d9cbe;\" href=\"https:\/\/drugtestsinbulk.com\/four-panel-prescreen-plus-dip-card-clia-waived-ps-doa-649.html\"><b>Four Panel PreScreen Plus Dip Card (CLIA Waived)<\/b><\/a><\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/drugtestsinbulk.com\/four-panel-prescreen-plus-dip-card-clia-waived-ps-doa-649.html\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone\" src=\"https:\/\/drugtestsinbulk.com\/media\/iopt\/catalog\/product\/cache\/9d08971813a040f8f96067a40f75c615\/P\/r\/PreScreen_Dip5_31_1.webp\" alt=\"Four Panel PreScreen Plus Dip Card (CLIA Waived)\" width=\"161\" height=\"213\" \/><\/a><\/p>\n<p style=\"text-align: center;\"><b>Detects: <\/b><span style=\"font-weight: 400;\">COC, mAMP, OPI, THC<\/span><\/p>\n<p style=\"text-align: center;\"><a class=\"product-btn\" href=\"https:\/\/drugtestsinbulk.com\/four-panel-prescreen-plus-dip-card-clia-waived-ps-doa-649.html\"><span style=\"font-weight: 400;\">View Product<\/span><\/a><\/p>\n<\/div>\n<div class=\"product-box\">\n<p style=\"text-align: center;\"><a style=\"color: #4d9cbe;\" href=\"https:\/\/drugtestsinbulk.com\/five-panel-clear-scan-drug-test-cup.html\"><b>Five Panel Clear Scan Drug Test Cup (CLIA Waived)<\/b><\/a><\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/drugtestsinbulk.com\/five-panel-clear-scan-drug-test-cup.html\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone\" src=\"https:\/\/drugtestsinbulk.com\/media\/iopt\/catalog\/product\/cache\/9d08971813a040f8f96067a40f75c615\/c\/l\/clearscan2_11.webp\" alt=\"Five Panel Clear Scan Drug Test Cup (CLIA Waived)\" width=\"161\" height=\"213\" \/><\/a><\/p>\n<p style=\"text-align: center;\"><b>Detects: <\/b><span style=\"font-weight: 400;\">AMP, COC, mAMP, OPI, THC<\/span><\/p>\n<p style=\"text-align: center;\"><a class=\"product-btn\" href=\"https:\/\/drugtestsinbulk.com\/five-panel-clear-scan-drug-test-cup.html\"><span style=\"font-weight: 400;\">View Product<\/span><\/a><\/p>\n<\/div>\n<div class=\"product-box\">\n<p style=\"text-align: center;\"><a style=\"color: #4d9cbe;\" href=\"https:\/\/drugtestsinbulk.com\/ten-panel-prescreen-plus-cup-with-adulterants-clia-waived.html\"><b>Ten Panel PreScreen Plus Cup With Adulterants (CLIA Waived)<\/b><\/a><\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/drugtestsinbulk.com\/ten-panel-prescreen-plus-cup-with-adulterants-clia-waived.html\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone\" src=\"https:\/\/drugtestsinbulk.com\/media\/iopt\/catalog\/product\/cache\/9d08971813a040f8f96067a40f75c615\/p\/r\/prescreen_cup2_6.webp\" alt=\"Ten Panel PreScreen Plus Cup With Adulterants (CLIA Waived)\" width=\"161\" height=\"213\" \/><\/a><\/p>\n<p style=\"text-align: center;\"><b>Detects: <\/b><span style=\"font-weight: 400;\">AMP, BAR, BZO, COC, MET, MDMA, MTD, OPI, PCP, THC + OX, PH, SG<\/span><\/p>\n<p style=\"text-align: center;\"><a class=\"product-btn\" href=\"https:\/\/drugtestsinbulk.com\/ten-panel-prescreen-plus-cup-with-adulterants-clia-waived.html\"><span style=\"font-weight: 400;\">View Product<\/span><\/a><\/p>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<ul>\n<li><b>RELATED:<\/b><a href=\"https:\/\/drugtestsinbulk.com\/blog\/best-drug-testing-kits-workplace-screening\/\"> <span style=\"font-weight: 400;\">Best Drug Testing Kits for Workplace Screening<\/span><\/a><\/li>\n<\/ul>\n<h3><b>Benefits of Buying Drug Test Kits in Bulk<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Bulk purchasing supports more efficient workplace testing operations and helps organizations maintain uninterrupted screening availability.<\/span><\/p>\n<ul>\n<li>\n<h4><b>Cost Savings<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">Large-volume purchasing often lowers per-unit pricing and reduces overall testing expenses for employers conducting routine screenings.<\/span><\/li>\n<li>\n<h4><b>Better Inventory Management<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">Maintaining adequate inventory helps avoid delays during onboarding, random testing, or post-accident screening situations.<\/span><\/li>\n<li>\n<h4><b>Consistent Product Availability<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">Reliable stock availability supports uninterrupted workplace compliance programs and reduces the need for emergency purchasing.<\/span><\/li>\n<li>\n<h4><b>Reduced Shipping Expenses<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">Consolidated orders typically reduce shipping frequency and transportation costs for businesses managing multiple testing locations.<\/span><\/li>\n<li>\n<h4><b>Simplified Compliance Planning<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">Standardized inventory makes it easier to maintain consistent workplace testing procedures and documentation practices.<\/span><\/li>\n<li>\n<h4><b>Faster Workplace Testing Procedures<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">Keeping sufficient inventory on hand helps employers conduct testing immediately when required, improving operational efficiency.<\/span><\/li>\n<\/ul>\n<h2 id=\"section6\"><b>FDA Cleared vs Approved: Key Takeaways for Test Kit Buyers<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Choosing between products labeled FDA cleared vs approved starts with understanding what each designation actually means. Most workplace drug test kits are FDA-cleared through the 510(k) pathway, which is the standard regulatory route for moderate-risk diagnostic devices.<\/span><\/p>\n<p>The most important factors are intended use, validation data, quality controls, and supplier reliability. For employers, an FDA-cleared test kit from a trusted supplier like <a href=\"https:\/\/drugtestsinbulk.com\/\">Drug Tests <strong>In Bulk<\/strong><\/a> is typically the right choice.<\/p>\n<h2><b>Frequently Asked Questions About FDA Cleared vs Approved<\/b><\/h2>\n<h3><b>Are FDA-Cleared Drug Tests Accurate?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Yes, FDA-cleared drug tests are considered highly reliable for initial screening purposes. Manufacturers must demonstrate that their products are safe, effective, and substantially equivalent to legally marketed devices already recognized by the FDA.<\/span><\/p>\n<h3><b>FDA Cleared vs Approved &#8211; Which One Is Better?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">FDA approval involves a different pathway used for higher-risk products. For workplace drug testing, FDA clearance is the standard and appropriate regulatory status.<\/span><\/p>\n<h3><b>What Does \u201dCleared By The FDA\u201d Mean For Drug Testing Kits?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">&#8220;Cleared by the FDA&#8221; means the U.S. Food and Drug Administration reviewed the product through the 510(k) premarket notification process and determined it is substantially equivalent to an existing legally marketed device. It confirms the kit is safe and effective for its intended screening use \u2014 whether in a clinical, workplace, or home setting.<\/span><\/p>\n<h3><b>Are Employers Required To Use FDA-Cleared Drug Tests?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Private employers are generally not federally required to use FDA-cleared kits for non-regulated testing, though many state laws mandate them for legal defensibility. Conversely, safety-sensitive industries regulated by the federal government\u2014such as the Department of Transportation\u2014must strictly adhere to SAMHSA-certified laboratory protocols.<\/span><\/p>\n<h3><b>What Does The FDA Regulate?<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">The FDA regulates a broad range of products to protect public health, including prescription and over-the-counter drugs, vaccines, biological products, medical devices, cosmetics, tobacco products, and radiation-emitting electronic devices.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Cleared vs Approved is one of the most misunderstood topics when buying drug test kits, medical devices, and screening products. Many buyers assume the terms mean the same thing, but they represent different FDA review pathways. Knowing the distinction helps businesses choose reliable products, avoid misleading claims, and purchase test kits that meet workplace [&hellip;]<\/p>\n","protected":false},"author":18,"featured_media":4225,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"wl_entities_gutenberg":"","_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[1],"tags":[563,561,560,562],"wl_entity_type":[397],"class_list":["post-4216","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-test-industry","tag-difference-between-fda-cleared-and-fda-approved","tag-fda-approved-vs-fda-cleared","tag-fda-cleared-vs-approved","tag-fda-cleared-vs-fda-approved","wl_entity_type-article"],"aioseo_notices":[],"_wl_alt_label":[],"wl:entity_url":"\/post\/fda-cleared-vs-approved-know-before-you-purchase-test-kits-4216","_links":{"self":[{"href":"https:\/\/drugtestsinbulk.com\/blog\/wp-json\/wp\/v2\/posts\/4216","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/drugtestsinbulk.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/drugtestsinbulk.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/drugtestsinbulk.com\/blog\/wp-json\/wp\/v2\/users\/18"}],"replies":[{"embeddable":true,"href":"https:\/\/drugtestsinbulk.com\/blog\/wp-json\/wp\/v2\/comments?post=4216"}],"version-history":[{"count":17,"href":"https:\/\/drugtestsinbulk.com\/blog\/wp-json\/wp\/v2\/posts\/4216\/revisions"}],"predecessor-version":[{"id":4240,"href":"https:\/\/drugtestsinbulk.com\/blog\/wp-json\/wp\/v2\/posts\/4216\/revisions\/4240"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/drugtestsinbulk.com\/blog\/wp-json\/wp\/v2\/media\/4225"}],"wp:attachment":[{"href":"https:\/\/drugtestsinbulk.com\/blog\/wp-json\/wp\/v2\/media?parent=4216"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/drugtestsinbulk.com\/blog\/wp-json\/wp\/v2\/categories?post=4216"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/drugtestsinbulk.com\/blog\/wp-json\/wp\/v2\/tags?post=4216"},{"taxonomy":"wl_entity_type","embeddable":true,"href":"https:\/\/drugtestsinbulk.com\/blog\/wp-json\/wp\/v2\/wl_entity_type?post=4216"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}