{"id":223,"date":"2025-02-01T07:59:09","date_gmt":"2025-02-01T07:59:09","guid":{"rendered":"https:\/\/satoriocs.com\/blogs\/?post_type=web-story&#038;p=223"},"modified":"2025-02-01T12:36:48","modified_gmt":"2025-02-01T12:36:48","slug":"usfdamedicaldeviceclassfication","status":"publish","type":"web-story","link":"https:\/\/satoriocs.com\/blogs\/web-stories\/usfdamedicaldeviceclassfication\/","title":{"rendered":"Understanding FDA Medical Device Classification\n&#x1f4e2; Before marketing a medical device in the U.S., it&#8217;s important to know how the FDA classifies it."},"content":{"rendered":"<p><html amp=\"\" lang=\"en\"><head><meta charSet=\"utf-8\"\/><meta name=\"viewport\" content=\"width=device-width,minimum-scale=1,initial-scale=1\"\/><script async=\"\" src=\"https:\/\/cdn.ampproject.org\/v0.js\"><\/script><script async=\"\" src=\"https:\/\/cdn.ampproject.org\/v0\/amp-story-1.0.js\" custom-element=\"amp-story\"><\/script><link 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title=\"Understanding FDA Medical Device Classification\n&amp;#x1f4e2; Before marketing a medical device in the U.S., it&#x27;s important to know how the FDA classifies it.\" poster-portrait-src=\"https:\/\/satoriocs.com\/blogs\/wp-content\/uploads\/2025\/02\/cropped-Understanding-FDA-Medical-Device-Risk-Classification-1.png\" background-audio=\"https:\/\/satoriocs.com\/blogs\/wp-content\/uploads\/2025\/02\/subway-mirage-261477.mp3\"><amp-story-page id=\"1531247d-9d44-43d1-8d71-61b3550879fa\" auto-advance-after=\"7s\"><amp-story-grid-layer template=\"vertical\" aspect-ratio=\"412:618\" class=\"grid-layer\"><\/p>\n<div class=\"page-fullbleed-area\" style=\"background-color:#e8e1e4\">\n<div class=\"page-safe-area\">\n<div style=\"position:absolute;pointer-events:none;left:0;top:-9.25926%;width:100%;height:118.51852%;opacity:1\">\n<div style=\"pointer-events:initial;width:100%;height:100%;display:block;position:absolute;top:0;left:0;z-index:0\" class=\"mask\" 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disable-inline-width=\"true\"><\/amp-img><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><\/amp-story-grid-layer><amp-story-grid-layer template=\"vertical\" aspect-ratio=\"412:618\" class=\"grid-layer\"><\/p>\n<div class=\"page-fullbleed-area\">\n<div class=\"page-safe-area\"><\/div>\n<\/div>\n<p><\/amp-story-grid-layer><\/amp-story-page><amp-story-page id=\"dad45760-591f-4657-9fc0-57c7b0a15661\" auto-advance-after=\"7s\"><amp-story-animation layout=\"nodisplay\" trigger=\"visibility\"><script type=\"application\/json\">[{\"selector\":\"#anim-a5ce8e2f-61dc-436e-8e9c-46ca7fa1ab3b\",\"keyframes\":[{\"offset\":0,\"transform\":\"translate3d(0, -216.53983%, 0)\",\"easing\":\"cubic-bezier(.5, 0, 1, 1)\"},{\"offset\":0.29,\"transform\":\"translate3d(0, 0%, 0)\",\"easing\":\"cubic-bezier(0, 0, .5, 1)\"},{\"offset\":0.45,\"transform\":\"translate3d(0, -60.891000196%, 0)\",\"easing\":\"cubic-bezier(.5, 0, 1, 1)\"},{\"offset\":0.61,\"transform\":\"translate3d(0, 0%, 0)\",\"easing\":\"cubic-bezier(0, 0, .5, 1)\"},{\"offset\":0.71,\"transform\":\"translate3d(0, -20.701207748%, 0)\",\"easing\":\"cubic-bezier(.5, 0, 1, 1)\"},{\"offset\":0.8,\"transform\":\"translate3d(0, 0%, 0)\",\"easing\":\"cubic-bezier(0, 0, .5, 1)\"},{\"offset\":0.85,\"transform\":\"translate3d(0, -7.773779897%, 0)\",\"easing\":\"cubic-bezier(.5, 0, 1, 1)\"},{\"offset\":0.92,\"transform\":\"translate3d(0, 0%, 0)\",\"easing\":\"cubic-bezier(0, 0, .5, 1)\"},{\"offset\":0.96,\"transform\":\"translate3d(0, -3.378021348%, 0)\",\"easing\":\"cubic-bezier(.5, 0, 1, 1)\"},{\"offset\":1,\"transform\":\"translate3d(0, 0%, 0)\",\"easing\":\"cubic-bezier(0, 0, .5, 1)\"}],\"delay\":0,\"duration\":600,\"fill\":\"both\"}]<\/script><\/amp-story-animation><amp-story-grid-layer template=\"vertical\" aspect-ratio=\"412:618\" class=\"grid-layer\"><\/p>\n<div class=\"page-fullbleed-area\" style=\"background-color:#fff\">\n<div class=\"page-safe-area\">\n<div style=\"position:absolute;pointer-events:none;left:0;top:-9.25926%;width:100%;height:118.51852%;opacity:1\">\n<div style=\"pointer-events:initial;width:100%;height:100%;display:block;position:absolute;top:0;left:0;z-index:0\" class=\"mask\" id=\"el-ee18bbab-cd6e-4de9-bb56-55ba38c6794a\">\n<div class=\"fill\" style=\"will-change:transform\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><\/amp-story-grid-layer><amp-story-grid-layer template=\"vertical\" aspect-ratio=\"412:618\" class=\"grid-layer\"><\/p>\n<div class=\"page-fullbleed-area\">\n<div class=\"page-safe-area\">\n<div style=\"position:absolute;pointer-events:none;left:7.52427%;top:32.03883%;width:84.95146%;height:35.43689%;opacity:1\">\n<div id=\"anim-a5ce8e2f-61dc-436e-8e9c-46ca7fa1ab3b\" class=\"animation-wrapper\" style=\"width:100%;height:100%;display:block;position:absolute;top:0;left:0;--initial-opacity:1;--initial-transform:translate3d(0, -216.53983%, 0)\">\n<div style=\"pointer-events:initial;width:100%;height:100%;display:block;position:absolute;top:0;left:0;z-index:0;border-radius:0.5714285714285714% 0.5714285714285714% 0.5714285714285714% 0.5714285714285714% \/ 0.91324200913242% 0.91324200913242% 0.91324200913242% 0.91324200913242%\" id=\"el-1a2a8d8f-11a6-40e5-8380-fc88bffc9412\">\n<h1 class=\"fill text-wrapper\" style=\"white-space:pre-line;overflow-wrap:break-word;word-break:break-word;margin:-0.48934151785714264% 0;font-family:&quot;Times New Roman&quot;,&quot;Times New Roman&quot;,&quot;Times&quot;,&quot;Baskerville&quot;,&quot;Georgia&quot;,serif;font-size:0.598706em;line-height:1.2;text-align:center;padding:0;color:#000000\"><span>&#x1f4e2; Before marketing a medical device in the U.S., it&#8217;s important to know how the FDA classifies it.<\/span><\/h1>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><\/amp-story-grid-layer><\/amp-story-page><amp-story-page id=\"a49c4eb7-c547-4414-aa31-211b7af05bc8\" auto-advance-after=\"7s\"><amp-story-animation layout=\"nodisplay\" trigger=\"visibility\"><script type=\"application\/json\">[{\"selector\":\"#anim-5bda099d-8556-41c6-a33d-07f0830072b5\",\"keyframes\":{\"opacity\":[0,1]},\"delay\":0,\"duration\":600,\"easing\":\"cubic-bezier(0.2, 0.6, 0.0, 1)\",\"fill\":\"both\"}]<\/script><\/amp-story-animation><amp-story-animation layout=\"nodisplay\" trigger=\"visibility\"><script type=\"application\/json\">[{\"selector\":\"#anim-94da41fa-010f-436b-874e-63631567cf2f\",\"keyframes\":{\"transform\":[\"translate3d(-113.79311%, 0px, 0)\",\"translate3d(0px, 0px, 0)\"]},\"delay\":0,\"duration\":600,\"easing\":\"cubic-bezier(0.2, 0.6, 0.0, 1)\",\"fill\":\"both\"}]<\/script><\/amp-story-animation><amp-story-grid-layer template=\"vertical\" aspect-ratio=\"412:618\" class=\"grid-layer\"><\/p>\n<div class=\"page-fullbleed-area\" style=\"background-color:#fff\">\n<div class=\"page-safe-area\">\n<div style=\"position:absolute;pointer-events:none;left:0;top:-9.25926%;width:100%;height:118.51852%;opacity:1\">\n<div style=\"pointer-events:initial;width:100%;height:100%;display:block;position:absolute;top:0;left:0;z-index:0\" class=\"mask\" id=\"el-911881d9-db03-4daf-8bdd-5b1d8c4dcc2c\">\n<div class=\"fill\" style=\"will-change:transform\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><\/amp-story-grid-layer><amp-story-grid-layer template=\"vertical\" aspect-ratio=\"412:618\" class=\"grid-layer\"><\/p>\n<div class=\"page-fullbleed-area\">\n<div class=\"page-safe-area\">\n<div style=\"position:absolute;pointer-events:none;left:11.65049%;top:-2.75081%;width:84.46602%;height:94.66019%;opacity:1\">\n<div id=\"anim-5bda099d-8556-41c6-a33d-07f0830072b5\" class=\"animation-wrapper\" style=\"width:100%;height:100%;display:block;position:absolute;top:0;left:0;--initial-opacity:0;--initial-transform:none\">\n<div id=\"anim-94da41fa-010f-436b-874e-63631567cf2f\" class=\"animation-wrapper\" style=\"width:100%;height:100%;display:block;position:absolute;top:0;left:0;--initial-opacity:1;--initial-transform:translate3d(-113.79311%, 0px, 0)\">\n<div style=\"pointer-events:initial;width:100%;height:100%;display:block;position:absolute;top:0;left:0;z-index:0;border-radius:0.5747126436781609% 0.5747126436781609% 0.5747126436781609% 0.5747126436781609% \/ 0.3418803418803419% 0.3418803418803419% 0.3418803418803419% 0.3418803418803419%\" id=\"el-cc9b3637-6e02-4e19-9fb1-a456c4ab0c45\">\n<h2 class=\"fill text-wrapper\" style=\"white-space:pre-line;overflow-wrap:break-word;word-break:break-word;margin:-0.4655509159482759% 0;font-family:&quot;Times New Roman&quot;,&quot;Times New Roman&quot;,&quot;Times&quot;,&quot;Baskerville&quot;,&quot;Georgia&quot;,serif;font-size:0.566343em;line-height:1.2;text-align:left;padding:0;color:#000000\"><span><span style=\"font-weight: 700; text-decoration: underline\">&nbsp;Class I \u2013 Low Risk<\/span><\/p>\n<p>&#x2705; Minimal potential harm<\/p>\n<p>&#x1f4cb; Basic regulatory controls apply<\/p>\n<p>&#x1f4cc; Examples: Bandages, Tongue Depressors<\/p>\n<p>&#x1f4dd; FDA Submission: 510(k) or Exempt<\/span><\/h2>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><\/amp-story-grid-layer><\/amp-story-page><amp-story-page id=\"7c19da27-3c03-4fa9-acc8-971a76972ed7\" auto-advance-after=\"7s\"><amp-story-animation layout=\"nodisplay\" trigger=\"visibility\"><script type=\"application\/json\">[{\"selector\":\"#anim-efc7f84e-ea6e-4210-9677-23b5cdfb8d5d\",\"keyframes\":[{\"offset\":0,\"transform\":\"translate3d(0, -140.00409%, 0)\",\"easing\":\"cubic-bezier(.5, 0, 1, 1)\"},{\"offset\":0.29,\"transform\":\"translate3d(0, 0%, 0)\",\"easing\":\"cubic-bezier(0, 0, .5, 1)\"},{\"offset\":0.45,\"transform\":\"translate3d(0, -39.369150108%, 0)\",\"easing\":\"cubic-bezier(.5, 0, 1, 1)\"},{\"offset\":0.61,\"transform\":\"translate3d(0, 0%, 0)\",\"easing\":\"cubic-bezier(0, 0, .5, 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1)\"}],\"delay\":0,\"duration\":600,\"fill\":\"both\"}]<\/script><\/amp-story-animation><amp-story-grid-layer template=\"vertical\" aspect-ratio=\"412:618\" class=\"grid-layer\"><\/p>\n<div class=\"page-fullbleed-area\" style=\"background-color:#fff\">\n<div class=\"page-safe-area\">\n<div style=\"position:absolute;pointer-events:none;left:0;top:-9.25926%;width:100%;height:118.51852%;opacity:1\">\n<div style=\"pointer-events:initial;width:100%;height:100%;display:block;position:absolute;top:0;left:0;z-index:0\" class=\"mask\" id=\"el-e71d3442-63bb-44c5-acba-3d92ec914ef5\">\n<div class=\"fill\" style=\"will-change:transform\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><\/amp-story-grid-layer><amp-story-grid-layer template=\"vertical\" aspect-ratio=\"412:618\" class=\"grid-layer\"><\/p>\n<div class=\"page-fullbleed-area\">\n<div class=\"page-safe-area\">\n<div style=\"position:absolute;pointer-events:none;left:11.65049%;top:12.13592%;width:82.28155%;height:87.86408%;opacity:1\">\n<div id=\"anim-efc7f84e-ea6e-4210-9677-23b5cdfb8d5d\" class=\"animation-wrapper\" style=\"width:100%;height:100%;display:block;position:absolute;top:0;left:0;--initial-opacity:1;--initial-transform:translate3d(0, -140.00409%, 0)\">\n<div style=\"pointer-events:initial;width:100%;height:100%;display:block;position:absolute;top:0;left:0;z-index:0;border-radius:0.5899705014749262% 0.5899705014749262% 0.5899705014749262% 0.5899705014749262% \/ 0.3683241252302026% 0.3683241252302026% 0.3683241252302026% 0.3683241252302026%\" id=\"el-58b3be4a-c60d-45e3-98db-707fa8f23077\">\n<h2 class=\"fill text-wrapper\" style=\"white-space:pre-line;overflow-wrap:break-word;word-break:break-word;margin:-0.47791067477876104% 0;font-family:&quot;Times New Roman&quot;,&quot;Times New Roman&quot;,&quot;Times&quot;,&quot;Baskerville&quot;,&quot;Georgia&quot;,serif;font-size:0.566343em;line-height:1.2;text-align:left;padding:0;color:#000000\"><span>&#x26a0;&#xfe0f; Higher risk than Class I<\/p>\n<p>&#x1f52c; Requires additional regulatory controls<\/p>\n<p>&#x1f4cc; Examples: Infusion Pumps, Diagnostic Ultrasound<\/p>\n<p>&#x1f4dd; FDA Submission: 510(k) (Some exemptions apply)<\/span><\/h2>\n<\/div>\n<\/div>\n<\/div>\n<div style=\"position:absolute;pointer-events:none;left:13.83495%;top:-3.23625%;width:72.3301%;height:13.1068%;opacity:1\">\n<div id=\"anim-b3a78e89-a222-422f-9cc4-21f0e8630327\" class=\"animation-wrapper\" style=\"width:100%;height:100%;display:block;position:absolute;top:0;left:0;--initial-opacity:1;--initial-transform:translate3d(0, -368.17553%, 0)\">\n<div style=\"pointer-events:initial;width:100%;height:100%;display:block;position:absolute;top:0;left:0;z-index:0;border-radius:0.6711409395973155% 0.6711409395973155% 0.6711409395973155% 0.6711409395973155% \/ 2.4691358024691357% 2.4691358024691357% 2.4691358024691357% 2.4691358024691357%\" id=\"el-dd50a0ba-063b-47cc-afaf-2754d938136d\">\n<h2 class=\"fill text-wrapper\" style=\"white-space:pre-line;overflow-wrap:break-word;word-break:break-word;margin:-0.5436634857382551% 0;font-family:&quot;Times New Roman&quot;,&quot;Times New Roman&quot;,&quot;Times&quot;,&quot;Baskerville&quot;,&quot;Georgia&quot;,serif;font-size:0.566343em;line-height:1.2;text-align:center;padding:0;color:#000000\"><span><span style=\"font-weight: 700; text-decoration: underline\">Class II \u2013 Moderate Risk<\/span><\/span><\/h2>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><\/amp-story-grid-layer><\/amp-story-page><amp-story-page id=\"3f468893-ea6d-44b4-9fc6-7b70964e7c78\" auto-advance-after=\"7s\"><amp-story-animation layout=\"nodisplay\" trigger=\"visibility\"><script type=\"application\/json\">[{\"selector\":\"#anim-c3cb7fc1-1023-4dd2-bb4f-6e2f9747f35f\",\"keyframes\":{\"opacity\":[0,1]},\"delay\":0,\"duration\":600,\"easing\":\"cubic-bezier(0.2, 0.6, 0.0, 1)\",\"fill\":\"both\"}]<\/script><\/amp-story-animation><amp-story-animation layout=\"nodisplay\" trigger=\"visibility\"><script type=\"application\/json\">[{\"selector\":\"#anim-10c933b3-f033-4657-91f1-32a6cadcf0cc\",\"keyframes\":{\"transform\":[\"translate3d(108.65671%, 0px, 0)\",\"translate3d(0px, 0px, 0)\"]},\"delay\":0,\"duration\":600,\"easing\":\"cubic-bezier(0.2, 0.6, 0.0, 1)\",\"fill\":\"both\"}]<\/script><\/amp-story-animation><amp-story-animation layout=\"nodisplay\" trigger=\"visibility\"><script type=\"application\/json\">[{\"selector\":\"#anim-7d96db38-eda7-42c7-9fb4-303089e35d58\",\"keyframes\":{\"opacity\":[0,1]},\"delay\":0,\"duration\":600,\"easing\":\"cubic-bezier(0.2, 0.6, 0.0, 1)\",\"fill\":\"both\"}]<\/script><\/amp-story-animation><amp-story-animation layout=\"nodisplay\" trigger=\"visibility\"><script type=\"application\/json\">[{\"selector\":\"#anim-40744a14-5be2-4831-8219-3c398367b2ed\",\"keyframes\":{\"transform\":[\"translate3d(118.56677%, 0px, 0)\",\"translate3d(0px, 0px, 0)\"]},\"delay\":0,\"duration\":600,\"easing\":\"cubic-bezier(0.2, 0.6, 0.0, 1)\",\"fill\":\"both\"}]<\/script><\/amp-story-animation><amp-story-grid-layer template=\"vertical\" aspect-ratio=\"412:618\" class=\"grid-layer\"><\/p>\n<div class=\"page-fullbleed-area\" style=\"background-color:#fff\">\n<div class=\"page-safe-area\">\n<div style=\"position:absolute;pointer-events:none;left:0;top:-9.25926%;width:100%;height:118.51852%;opacity:1\">\n<div style=\"pointer-events:initial;width:100%;height:100%;display:block;position:absolute;top:0;left:0;z-index:0\" class=\"mask\" id=\"el-c3aa4613-ef22-4ec6-9e73-3c124257a82a\">\n<div class=\"fill\" style=\"will-change:transform\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><\/amp-story-grid-layer><amp-story-grid-layer template=\"vertical\" aspect-ratio=\"412:618\" class=\"grid-layer\"><\/p>\n<div class=\"page-fullbleed-area\">\n<div class=\"page-safe-area\">\n<div style=\"position:absolute;pointer-events:none;left:11.65049%;top:5.17799%;width:81.31068%;height:94.66019%;opacity:1\">\n<div id=\"anim-c3cb7fc1-1023-4dd2-bb4f-6e2f9747f35f\" class=\"animation-wrapper\" style=\"width:100%;height:100%;display:block;position:absolute;top:0;left:0;--initial-opacity:0;--initial-transform:none\">\n<div id=\"anim-10c933b3-f033-4657-91f1-32a6cadcf0cc\" class=\"animation-wrapper\" style=\"width:100%;height:100%;display:block;position:absolute;top:0;left:0;--initial-opacity:1;--initial-transform:translate3d(108.65671%, 0px, 0)\">\n<div style=\"pointer-events:initial;width:100%;height:100%;display:block;position:absolute;top:0;left:0;z-index:0;border-radius:0.5970149253731344% 0.5970149253731344% 0.5970149253731344% 0.5970149253731344% \/ 0.3418803418803419% 0.3418803418803419% 0.3418803418803419% 0.3418803418803419%\" id=\"el-f567b93f-875c-460e-8771-67e694ed6a59\">\n<h2 class=\"fill text-wrapper\" style=\"white-space:pre-line;overflow-wrap:break-word;word-break:break-word;margin:-0.4836170708955224% 0;font-family:&quot;Times New Roman&quot;,&quot;Times New Roman&quot;,&quot;Times&quot;,&quot;Baskerville&quot;,&quot;Georgia&quot;,serif;font-size:0.566343em;line-height:1.2;text-align:left;padding:0;color:#000000\"><span><br \/>\n&#x1f6a8; Sustains\/supports life or has high risk<\/p>\n<p>&#x1f9d1;&#x200d;&#x2695;&#xfe0f; Strict regulatory requirements apply<\/p>\n<p>&#x1f4cc; Examples: Pacemakers, Heart Valves<\/p>\n<p>&#x1f4dd; FDA Submission: PMA (Pre-Market Approval)<\/span><\/h2>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div style=\"position:absolute;pointer-events:none;left:11.65049%;top:-1.2945%;width:74.51456%;height:12.94498%;opacity:1\">\n<div id=\"anim-7d96db38-eda7-42c7-9fb4-303089e35d58\" class=\"animation-wrapper\" style=\"width:100%;height:100%;display:block;position:absolute;top:0;left:0;--initial-opacity:0;--initial-transform:none\">\n<div id=\"anim-40744a14-5be2-4831-8219-3c398367b2ed\" class=\"animation-wrapper\" style=\"width:100%;height:100%;display:block;position:absolute;top:0;left:0;--initial-opacity:1;--initial-transform:translate3d(118.56677%, 0px, 0)\">\n<div style=\"pointer-events:initial;width:100%;height:100%;display:block;position:absolute;top:0;left:0;z-index:0;border-radius:0.6514657980456027% 0.6514657980456027% 0.6514657980456027% 0.6514657980456027% \/ 2.5% 2.5% 2.5% 2.5%\" id=\"el-3f1d17f5-59d6-4d75-8881-521a9d7ab0c4\">\n<h2 class=\"fill text-wrapper\" style=\"white-space:pre-line;overflow-wrap:break-word;word-break:break-word;margin:-0.5277254682410424% 0;font-family:&quot;Times New Roman&quot;,&quot;Times New Roman&quot;,&quot;Times&quot;,&quot;Baskerville&quot;,&quot;Georgia&quot;,serif;font-size:0.566343em;line-height:1.2;text-align:center;padding:0;color:#000000\"><span><span style=\"font-weight: 700; text-decoration: underline\">Class III \u2013 High Risk<\/span><\/span><\/h2>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><\/amp-story-grid-layer><\/amp-story-page><amp-story-page id=\"abdfba2c-3b89-4bd2-a8af-ee5ad8e90497\" auto-advance-after=\"7s\"><amp-story-animation layout=\"nodisplay\" trigger=\"visibility\"><script type=\"application\/json\">[{\"selector\":\"#anim-26943d49-7698-4d6c-9c86-b054b409f284\",\"keyframes\":{\"transform\":[\"scale(1)\",\"scale(1.5)\",\"scale(0.95)\",\"scale(1)\"],\"offset\":[0,0.33,0.66,1]},\"delay\":0,\"duration\":1450,\"easing\":\"ease-in-out\",\"fill\":\"both\",\"iterations\":1}]<\/script><\/amp-story-animation><amp-story-animation layout=\"nodisplay\" trigger=\"visibility\"><script 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0.6349206349206349% \/ 0.39920159680638717% 0.39920159680638717% 0.39920159680638717% 0.39920159680638717%\" id=\"el-da58fa64-adfc-4e49-88f4-c0ae718d1451\"><a href=\"https:\/\/api.whatsapp.com\/send?phone=919829098077&amp;text=Satori%20Global%20Health%20Care%20Product%20Consultancy%20Services\" data-tooltip-icon=\"https:\/\/static.whatsapp.net\/rsrc.php\/v4\/yR\/r\/y8-PTBaP90a.png\" data-tooltip-text=\"Share on WhatsApp\" target=\"_blank\" rel=\"sponsored noreferrer\" style=\"width:100%;height:100%;display:block;position:absolute;top:0;left:0\"><\/p>\n<h2 class=\"fill text-wrapper\" style=\"white-space:pre-line;overflow-wrap:break-word;word-break:break-word;margin:-0.5143229166666666% 0;font-family:&quot;Times New Roman&quot;,&quot;Times New Roman&quot;,&quot;Times&quot;,&quot;Baskerville&quot;,&quot;Georgia&quot;,serif;font-size:0.566343em;line-height:1.2;text-align:left;padding:0;color:#000000\"><span><span style=\"font-weight: 700\">&nbsp;Need FDA 510(k) or PMA 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style=\"pointer-events:initial;width:100%;height:100%;display:block;position:absolute;top:0;left:0;z-index:0;border-radius:1.0582010582010581% 1.0582010582010581% 1.0582010582010581% 1.0582010582010581% \/ 4.761904761904762% 4.761904761904762% 4.761904761904762% 4.761904761904762%\" id=\"el-dfa67635-71a7-4a1c-8de4-f804e73f9506\"><a href=\"https:\/\/api.whatsapp.com\/send?phone=919829098077&amp;text=Satori%20Global%20Health%20Care%20Product%20Consultancy%20Services\" data-tooltip-icon=\"https:\/\/static.whatsapp.net\/rsrc.php\/v4\/yR\/r\/y8-PTBaP90a.png\" data-tooltip-text=\"Share on WhatsApp\" target=\"_blank\" rel=\"noreferrer\" style=\"width:100%;height:100%;display:block;position:absolute;top:0;left:0\"><\/p>\n<h2 class=\"fill text-wrapper\" style=\"white-space:pre-line;overflow-wrap:break-word;word-break:break-word;margin:0;font-family:&quot;Times New Roman&quot;,&quot;Times New Roman&quot;,&quot;Times&quot;,&quot;Baskerville&quot;,&quot;Georgia&quot;,serif;font-size:0.485437em;line-height:calc(1.2em + 0.2666669413332729em);text-align:center;padding:0;color:#000000;background-color:#ffd900;background:none\"><span style=\"display:block;position:relative;left:0;top:0;margin:-0.7347470238095238% 0;-webkit-box-decoration-break:clone;box-decoration-break:clone\"><span style=\"background-color:#ffd900;-webkit-box-decoration-break:clone;box-decoration-break:clone;position:relative;padding:2.1164021164021163% 4.232804232804233%;text-align:center;border-radius:2px 2px 2px 2px;color:transparent\"><span style=\"font-weight: 700\">Click Here&nbsp;<\/span><\/span><\/span><\/h2>\n<h2 class=\"fill text-wrapper\" style=\"white-space:pre-line;overflow-wrap:break-word;word-break:break-word;margin:0;font-family:&quot;Times New Roman&quot;,&quot;Times New Roman&quot;,&quot;Times&quot;,&quot;Baskerville&quot;,&quot;Georgia&quot;,serif;font-size:0.485437em;line-height:calc(1.2em + 0.2666669413332729em);text-align:center;padding:0;color:#000000;background-color:#ffd900;background:none;position:absolute;top:0;left:0;right:0\" aria-hidden=\"true\"><span style=\"display:block;position:relative;left:0;top:0;margin:-0.7347470238095238% 0;-webkit-box-decoration-break:clone;box-decoration-break:clone\"><span style=\"background-color:#ffd900;-webkit-box-decoration-break:clone;box-decoration-break:clone;position:relative;padding:2.1164021164021163% 4.232804232804233%;text-align:center;border-radius:2px 2px 2px 2px;background:none\"><span style=\"font-weight: 700\">Click Here&nbsp;<\/span><\/span><\/span><\/h2>\n<p><\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><\/amp-story-grid-layer><\/amp-story-page><\/amp-story><\/body><\/html><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Understanding FDA Medical Device Classification<br \/>\n&#x1f4e2; Before marketing a medical device in the U.S., it&#8217;s important to know how the FDA classifies it.<\/p>\n","protected":false},"author":1,"featured_media":233,"template":"","meta":{"pagelayer_contact_templates":[],"_pagelayer_content":"","web_stories_publisher_logo":227,"web_stories_poster":[],"web_stories_products":[],"footnotes":""},"web_story_category":[31],"web_story_tag":[32,33],"class_list":["post-223","web-story","type-web-story","status-publish","has-post-thumbnail","hentry"],"story_data":{"version":47,"pages":[{"elements":[{"opacity":100,"flip":{"vertical":false,"horizontal":false},"rotationAngle":0,"lockAspectRatio":false,"scale":100,"focalX":50,"focalY":50,"resource":{"type":"image","mimeType":"image\/png","width":720,"height":1280,"sizes":{"medium":{"file":"Understanding-FDA-Medical-Device-Risk-Classification-1-169x300.png","width":169,"height":300,"filesize":76664,"mimeType":"image\/png","sourceUrl":"https:\/\/satoriocs.com\/blogs\/wp-content\/uploads\/2025\/02\/Understanding-FDA-Medical-Device-Risk-Classification-1-169x300.png"},"large":{"file":"Understanding-FDA-Medical-Device-Risk-Classification-1-576x1024.png","width":576,"height":1024,"filesize":622740,"mimeType":"image\/png","sourceUrl":"https:\/\/satoriocs.com\/blogs\/wp-content\/uploads\/2025\/02\/Understanding-FDA-Medical-Device-Risk-Classification-1-576x1024.png"},"thumbnail":{"file":"Understanding-FDA-Medical-Device-Risk-Classification-1-150x150.png","width":150,"height":150,"filesize":36520,"mimeType":"image\/png","sourceUrl":"https:\/\/satoriocs.com\/blogs\/wp-content\/uploads\/2025\/02\/Understanding-FDA-Medical-Device-Risk-Classification-1-150x150.png"},"web-stories-poster-portrait":{"file":"Understanding-FDA-Medical-Device-Risk-Classification-1-640x853.png","width":640,"height":853,"filesize":580449,"mimeType":"image\/png","sourceUrl":"https:\/\/satoriocs.com\/blogs\/wp-content\/uploads\/2025\/02\/Understanding-FDA-Medical-Device-Risk-Classification-1-640x853.png"},"web-stories-publisher-logo":{"file":"Understanding-FDA-Medical-Device-Risk-Classification-1-96x96.png","width":96,"height":96,"filesize":16932,"mimeType":"image\/png","sourceUrl":"https:\/\/satoriocs.com\/blogs\/wp-content\/uploads\/2025\/02\/Understanding-FDA-Medical-Device-Risk-Classification-1-96x96.png"},"web-stories-thumbnail":{"file":"Understanding-FDA-Medical-Device-Risk-Classification-1-150x267.png","width":150,"height":267,"filesize":62292,"mimeType":"image\/png","sourceUrl":"https:\/\/satoriocs.com\/blogs\/wp-content\/uploads\/2025\/02\/Understanding-FDA-Medical-Device-Risk-Classification-1-150x267.png"},"full":{"file":"Understanding-FDA-Medical-Device-Risk-Classification-1.png","width":720,"height":1280,"mimeType":"image\/png","sourceUrl":"https:\/\/satoriocs.com\/blogs\/wp-content\/uploads\/2025\/02\/Understanding-FDA-Medical-Device-Risk-Classification-1.png"}},"isPlaceholder":false,"isExternal":false,"needsProxy":false,"baseColor":"#e8e1e4","blurHash":"U5Pj111GXS~C0@{_L2NH~qTekXDiD4k;-B?c","creationDate":1738394952000,"src":"https:\/\/satoriocs.com\/blogs\/wp-content\/uploads\/2025\/02\/Understanding-FDA-Medical-Device-Risk-Classification-1.png","id":228,"alt":"Understanding FDA Medical Device Risk Classification (1)","local":false},"type":"image","x":0,"y":-60,"width":412,"height":734,"mask":{"type":"rectangle","showInLibrary":true,"name":"Rectangle","path":"M 0,0 1,0 1,1 0,1 0,0 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New Roman"},"fontSize":37,"backgroundColor":{"color":{"r":196,"g":196,"b":196}},"lineHeight":1.2,"textAlign":"center","padding":{"locked":true,"hasHiddenPadding":false,"horizontal":0,"vertical":0},"content":"\ud83d\udce2 Before marketing a medical device in the U.S., it's important to know how the FDA classifies it.","x":31,"y":198,"width":350,"borderRadius":{"locked":true,"topLeft":2,"topRight":2,"bottomRight":2,"bottomLeft":2},"type":"text","height":219,"id":"1a2a8d8f-11a6-40e5-8380-fc88bffc9412"}],"backgroundColor":{"color":{"r":255,"g":255,"b":255}},"id":"dad45760-591f-4657-9fc0-57c7b0a15661","animations":[{"id":"5226bfc0-6b86-47a3-ab9d-ccaba7ea6366","type":"effect-drop","duration":600,"delay":0,"targets":["1a2a8d8f-11a6-40e5-8380-fc88bffc9412"]}]},{"elements":[{"opacity":100,"flip":{"vertical":false,"horizontal":false},"rotationAngle":0,"lockAspectRatio":true,"backgroundColor":{"color":{"r":196,"g":196,"b":196}},"x":1,"y":1,"width":1,"height":1,"mask":{"type":"rectangle"},"isBackground":true,"isDefaultBackground":true,"type":"shape","id":"911881d9-db03-4daf-8bdd-5b1d8c4dcc2c"},{"opacity":100,"flip":{"vertical":false,"horizontal":false},"rotationAngle":0,"lockAspectRatio":true,"backgroundTextMode":"NONE","font":{"family":"Times New 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