{"id":4484,"date":"2015-11-03T01:06:42","date_gmt":"2015-11-03T01:06:42","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=4484"},"modified":"2015-11-03T01:06:42","modified_gmt":"2015-11-03T01:06:42","slug":"fda-draft-guidance-on-info-to-support-a-claim-of-emc-for-medical-devices","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2015\/11\/03\/fda-draft-guidance-on-info-to-support-a-claim-of-emc-for-medical-devices\/","title":{"rendered":"FDA Draft Guidance – Info to Support a Claim of EMC for Medical Devices"},"content":{"rendered":"

\"FDA<\/a>On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”<\/a><\/strong>. \u00a0The Guidance was developed to describe the types of information that the FDA expects to be provided in a premarket submission to support a claim of Electromagnetic compatibility (EMC) for electrically-powered medical devices. \u00a0The FDA specifically defines, for this Guidance document, that EMC is “the ability of a device to function (a) properly in its\u00a0intended electromagnetic environment, including immunity to electromagnetic disturbance\u00a0(interference1<\/a><\/sup>), and (b) without introducing excessive electromagnetic disturbances (emissions) that might interfere with other devices.”<\/p>\n

A reminder that FDA Guidances and Recognized Consensus Standards are voluntary. \u00a0But I remind my clients’ that if you don’t use these voluntary documents for premarket submissions you make your life and the reviewer’s life a lot harder, typically. \u00a0So, I recommend, in most cases, to use these voluntary documents to speed up the process, in the long run. \u00a0In the short run, you may need to do more testing but if you don’t you risk the chance of your product not being accepted\u00a0by the FDA.<\/p>\n

The Guidance goes on to say that “the review of EMC information in a submission is based on the\u00a0risk associated with\u00a0EMC malfunction or degradation of the device under review, as well as the use of appropriate\u00a0FDA-recognized standards or appropriate consensus standards.” \u00a0The Guidance indicates that manufacturers typically reference in premarket submissions Recognized consesnsus national (US) and international standards such as IEC 60601-1-22<\/a><\/sup>) (3rd or 4th edition) Medical Electrical Equipment EMC standard, device specific Particular Standards such as IEC 60601-2-XX, and lastly they reference other consensus standards for electrically-powered deevices that include information on EMC such as ISO 147083<\/a><\/sup> for active implantable medical devices.<\/p>\n

The Guidance continues\u00a0with a listing of details that FDA is expecting\u00a0manufacturer’s provide in their premarket submissions, so the medical device EMC information is\u00a0clear and consistent information for the submission, and are consistent with the specifications included in the standards, as referenced above, that are applied to the premarket submission. \u00a0The Guidance points to the FDA Recognized Consensus Standards database located at\u00a0http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfStandards\/search.cfm<\/a><\/strong>.<\/p>\n

The rest of the Guidance<\/a>,<\/strong> Section II “EMC Information”, details the list of items the FDA is expecting of the manufacturer’s for premarket submissions. \u00a0And of course the FDA leaves an opening for a broad statement at the end of the section that says: “Additional information not outlined above may be requested by FDA depending on intended use and intended use environment for specific active medical devices (e.g. implantable portions of active devices) to demonstrate the device\u2019s claims regarding electromagnetic compatibility (EMC).”<\/p>\n

If you need help with this FDA Draft Guidance or with\u00a0IEC 60601-1-2\u00a0edition 3 or edition\u00a04\u00a0or you are interested in\u00a0our new\u00a0Eisner Safety Consultants\u00a0Standards Reconnaissance Database<\/a><\/strong>\u00a0please\u00a0email Leo Eisner directly at\u00a0Leo@EisnerSafety.com<\/a><\/strong>, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly\/EisnerSafetyConsultants<\/a><\/strong>).<\/p>\n

\n

Footnotes cited from FDA Draft Guidance Document issued on 2 Nov 2015 titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”<\/sup><\/p>\n

1. According to International definitions, \u201cdisturbance\u201d is the cause and \u201cinterference\u201d is the effect. In the US,\u00a0\u201cinterference\u201d is often used interchangeably for both cause and effect though more often for the cause.\u00a0\u21a9<\/a><\/sup>
\n2.\u00a0IEC 60601-1-2: 2007 [3rd<\/sup> Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety –\u00a0Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, IEC 60601-1-2:2014 [4th<\/sup> Ed.],\u00a0Medical Electrical Equipment, Part 1 2: General Requirements for Basic Safety and Essential Performance \u2013\u00a0Collateral Standard: Electromagnetic Disturbances \u2013 Requirements and Tests, AAMI\/ANSI\/IEC 60601-1-2: 2007\u00a0[3rd<\/sup> Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard:\u00a0Electromagnetic Compatibility – Requirements and Tests, and AAMI\/ANSI\/IEC 60601-1-2: 2014 [4th<\/sup> Ed.]:Medical\u00a0Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic\u00a0Disturbances – Requirements and Tests\u00a0<\/sup>\u21a9<\/a>
\n3. ISO 14708-3 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators \u21a9<\/a><\/sup><\/p>\n","protected":false},"excerpt":{"rendered":"

On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”. \u00a0The Guidance was developed to describe the types of information that the FDA expects to be<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[1266,45,61,15,16,39,539,62,403,54,41,47,404,163,74,1267,40,27,9,10,13,218,1163,1164,1204,1165,1205,53,94,1206,1268,22,330,174,175,149,5],"class_list":["post-4484","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-1266","tag-510k","tag-60601-series","tag-60601-1","tag-60601-1-3rd-ed","tag-60601-1-2","tag-60601-2-xx","tag-60601-2-xx-particular-stds","tag-a1","tag-aami","tag-aami-es60601-1","tag-aami-es60601-1c1","tag-amendment-1","tag-ansiaami-es60601-1","tag-cdrh","tag-electromagnetic-compatibility","tag-emc","tag-escnews","tag-fda","tag-fda-guidance","tag-iec","tag-iec-60601-1","tag-iec-60601-1-2","tag-iec-60601-1-2-3rd-edition","tag-iec-60601-1-2-4th-ed","tag-iec-60601-1-2-4th-edition","tag-iec-60601-1-22014","tag-iec60601-1","tag-iec60601-1-3rd-ed","tag-iec60601-1-2","tag-iso-14708","tag-medical","tag-medical-device","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-risk-management"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4484","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=4484"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4484\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=4484"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=4484"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=4484"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}