{"id":4211,"date":"2015-04-30T18:35:35","date_gmt":"2015-04-30T18:35:35","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=4211"},"modified":"2015-04-30T18:35:35","modified_gmt":"2015-04-30T18:35:35","slug":"part-2-wearables-the-rage-but-are-they-medical-devices","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2015\/04\/30\/part-2-wearables-the-rage-but-are-they-medical-devices\/","title":{"rendered":"Part 2 – Wearables the rage but are they medical devices?"},"content":{"rendered":"

\"\"<\/a>Part 2 of series Posts – \u201cGeneral Wellness\u201d & \u201cMedical Device Accessories\u201d FDA Guidances\u00a0in regard to Wearables. Join us @ 10X conference & learn more<\/span><\/p>\n

From the<\/span> previous \u201cWearables the rage but are they medical devices?\u201d blog post<\/a><\/strong> I indicated that to determine if Wearables are medical devices you must a) review the definition of a medical device per Section 201(h) of the FD&C Act against the intended use of the device & it\u2019s indications for use, and b) review a slew of recently released FDA guidance documents & related standards that supports those Guidance documents.<\/span><\/p>\n

So, let\u2019s continue with the \u201cGeneral Wellness\u201d guidance document. \u00a0The draft guidance is titled\u00a0<\/span>\u201cGeneral Wellness \u2013 Policy for Low Risk Devices\u201d<\/a><\/strong><\/p>\n

Many wearables may fall under the category of \u201cgeneral wellness\u201d. Let\u2019s see how this guidance may apply to Wearables.<\/span><\/p>\n

The draft guidance document was recently released on January 20, 2015.\u00a0 It covers the policy for low risk products that promote a healthy lifestyle (General wellness products). This could be like a Fitbit\u00ae\u00a0<\/strong>or similar consumer oriented type of wearable devices that are on the market (Apple Watch<\/span>\u2122<\/strong>, Microsoft Band, etc.). The FDA from a recent <\/span>webinar<\/a><\/strong> and in the guidance document roughly said that it does not intend to examine, regulate & enforces \u201cgeneral wellness\u201d products, if they meet the low risk definition that is in the guidance document. \u00a0This doesn’t mean that other Federal Agencies or Regulations won’t regulate these devices like the FTC, FCC, HIPAA, COPA, etc. \u00a0The guidance has several lists of examples of \u201cgeneral wellness\u201d devices including weight management; stress management (i.e. a mobile apps that plays music to \u201csoothe & relax\u201d an individual and to \u201cmanage stress\u201d); and products that promote physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure.\u00a0 On the last page of the guidance there is a Decision Algorithm for General Wellness Products where the first section deals with \u201cDoes the product make only general wellness claims?\u201d and the 2<\/span>nd<\/sup> part asks, \u201cDoes the product present inherent risks to a user\u2019s safety (i.e. is the device low risk)?\u201d \u00a0You need to make sure to clearly go through this Algorithm to decide where you product really falls. \u00a0You may want to enlist an FDA lawyer or a Regulatory Consultant if you are not familiar with the FDA regulations.<\/span><\/p>\n

The next FDA Guidance document we will discuss is about Medical Device Accessories.\u00a0 The Guidance is titled \u201cMedical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types\u201d<\/a>.<\/strong>\u00a0 It is a draft guidance document and was issued on the same date as the \u201cGeneral Wellness\u201d Guidance of 1\/20\/15.\u00a0 The webinar<\/a><\/strong> that covered the \u201cGeneral Wellness\u201d Draft Guidance also discussed this Guidance document and the Mobile Medical Applications Guidance<\/a><\/strong> as well, as they are interrelated to some extent and so it makes sense that they all have some component related to Wearables then, as well.\u00a0 The Guidance deals with if the accessory needs to maintain the same classification as it\u2019s parent device or if you can down classify the accessory and not be as restricted because of a higher classification. It depends on if the accessory has a lower risk profile than their parent device & if so may warrant being regulated in a lower class per the Guidance document.\u00a0 So, less regulation on the accessory which is the theme of all the guidances in this blog post & for the Mobile Medical Applications Guidance<\/a><\/strong> too. The guidance advises the user of it that the FDA has jurisdiction over accessories because the definition of a medical device provided in FD&C Act Section 201(h) defines \u201cdevice\u201d to include, among other things, an \u201caccessory\u201d.\u00a0 In the past the FDA traditionally determined classification of device accessories in 1 of 2 ways: 1) by inclusion in the same classification as the parent device thru either the 510(k) premarket notification clearance process, the PMA approval process or by inclusion in the classification regulation or order[1]<\/a> for the parent device; or 2) by issuance of a unique, separate classification regulation or order for the accessory.\u00a0 The scope of the guidance clarifies how FDA\u2019s risk-based framework for classification applies to accessories to other medical devices. The guidance also describes use of the de novo classification process to classify accessories of a new type (not previously classified) under Section 513 (f)(2) of the FD&C Act.<\/span><\/p>\n

This warps up this part of the blog post series for wearables and I will continue in a future post or two to cover additional guidances such as Cybersecuitry, EMC, and Wireless Guidances as related to Wearables.<\/span><\/p>\n

If you want to learn more about these Wearable Guidance documents that are related to 510k submissions to the US FDA, I am teaching a 510k workshop in San Diego on May 4, 2015 as part of the\u00a0Medical Device Group 10x Conference<\/a><\/strong>. To get a great last minute discount and to reserve a spot at the conference or just the workshop contact Joe Hage at\u00a0jhage at MedicalDeviceEvents dot com<\/a><\/strong>\u00a0and he will provide you a with special rate if you mention Eisner Safety Consultants referred you to him.<\/span><\/p>\n

Two other consultants on the Eisner Safety Consultants team will teach the workshop:\u00a0Allison Komiyama<\/a><\/strong>\u00a0and\u00a0Robert Packard<\/a><\/strong>.<\/span><\/p>\n

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[1]<\/a> From the Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types \u201cPrior to the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), FDA reclassified devices under Section 513(e) of the FD&C Act through rulemaking; FDASIA changed this to an order process.\u201d<\/span><\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Part 2 of series Posts – \u201cGeneral Wellness\u201d & \u201cMedical Device Accessories\u201d FDA Guidances\u00a0in regard to Wearables. Join us @ 10X conference & learn more From the previous \u201cWearables the rage but are they medical devices?\u201d blog post I indicated<\/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":[61,15,16,54,41,47,74,92,27,9,10,93,88,89,91,13,218,94,95,22,174,175,149,1213,1214],"class_list":["post-4211","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-60601-series","tag-60601-1","tag-60601-1-3rd-ed","tag-aami","tag-aami-es60601-1","tag-aami-es60601-1c1","tag-cdrh","tag-collateral-standard","tag-escnews","tag-fda","tag-fda-guidance","tag-home-healthcare-environments","tag-home-use","tag-home-use-environment","tag-home-use-med-dvcs","tag-iec","tag-iec-60601-1","tag-iec60601-1-3rd-ed","tag-iec60601-1-11","tag-medical","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-wearable","tag-wearables"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4211","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=4211"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4211\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=4211"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=4211"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=4211"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}