{"id":533,"date":"2016-07-28T19:05:28","date_gmt":"2016-07-28T19:05:28","guid":{"rendered":"https:\/\/awrightpath.net\/?p=533"},"modified":"2019-06-05T19:08:15","modified_gmt":"2019-06-05T19:08:15","slug":"cdrh-industry-announcing-the-general-wellness-policy-for-low-risk-devices-final-guidance-and-webinar-on-september-1-2016","status":"publish","type":"post","link":"https:\/\/awrightpath.net\/cdrh-industry-announcing-the-general-wellness-policy-for-low-risk-devices-final-guidance-and-webinar-on-september-1-2016\/","title":{"rendered":"CDRH Industry: Announcing the General Wellness: Policy for Low-Risk Devices Final Guidance and Webinar on September 1, 2016"},"content":{"rendered":"\n<p>Today, the FDA issued a final guidance document titled&nbsp;<a href=\"http:\/\/www.fda.gov\/downloads\/medicaldevices\/deviceregulationandguidance\/guidancedocuments\/ucm429674.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">General Wellness: Policy for Low-Risk Devices<\/a>.<\/p>\n\n\n\n<p>The guidance explains that the FDA does not intend to actively regulate low-risk technologies that are intended only for general wellness use.&nbsp; The FDA encourages the development of general wellness technologies, such as fitness trackers or mobile apps, which can empower individuals to take a more active role in their health. The FDA will continue to focus its oversight on medical devices that may pose inherent risks to a user?s safety.<\/p>\n\n\n\n<p>Key changes from the draft guidance include:<\/p>\n\n\n\n<ul><li>Clarifying that CDRH?s general wellness policy does not apply to devices that present risks to users? or other persons? safety.<\/li><li>Identifying where the FDA will continue to focus oversight.&nbsp; The FDA does not consider a general wellness product to be low risk if any of the following apply:<ul><li>Is the product invasive?<\/li><li>Is the product implanted?<\/li><li>Does the product involve technology that may pose a risk to a user?s safety if regulatory controls are not applied, such as risks from lasers, radiation exposure, or electrical stimulation?<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>FDA Webinar to discuss the General Wellness:&nbsp; Policy for Low-Risk Devices Final Guidance on September 1, 2016<\/strong><\/p>\n\n\n\n<p>The FDA will hold a webinar to help manufacturers understand the information provided in this final guidance document. Following a brief presentation, the FDA will respond to participants? questions. We welcome your questions about this final guidance, so please mark your calendars to participate. No registration is required.888-566-5974, passcode: 7768031<br>International Callers Dial:&nbsp;<a href=\"tel:1-210-234-0118\" target=\"_blank\" rel=\"noreferrer noopener\">1-210-234-0118<\/a>&nbsp;passcode: 7768031<\/p>\n\n\n\n<p>To view the slide presentation during the webinar:<br>Participants can join the event directly at:&nbsp;<a href=\"https:\/\/www.mymeetings.com\/nc\/join.php\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.mymeetings.com\/nc\/join.php?i=PW9442410&amp;p=7768031&amp;t=c<\/a><br>Conference number: PW9442410<br>Audience passcode: 7768031<\/p>\n\n\n\n<p>To ensure you are connected, please dial-in 15 minutes&nbsp;prior to the start of the webinar.<\/p>\n\n\n\n<p>Following the webinar, a transcript, recording and slides will be available at:&nbsp;<a href=\"http:\/\/www.fda.gov\/CDRHWebinar\" target=\"_blank\" rel=\"noreferrer noopener\">http:\/\/www.fda.gov\/CDRHWebinar<\/a>. The slide presentation will be available at this site on the morning of the webinar.<\/p>\n\n\n\n<p>If you have any questions regarding this guidance document, please contact CDRH?s Division of Industry and Consumer Education (DICE) at&nbsp;<a href=\"mailto:dice@fda.hhs.gov\" target=\"_blank\" rel=\"noreferrer noopener\">dice@fda.hhs.gov<\/a>,&nbsp;<a href=\"tel:1-800-638-2041\" target=\"_blank\" rel=\"noreferrer noopener\">1-800-638-2041<\/a>, or&nbsp;<a href=\"tel:301-796-7100\" target=\"_blank\" rel=\"noreferrer noopener\">301-796-7100<\/a>.<\/p>\n\n\n\n<p>Thank you,<br>Food and Drug Administration<br>Center for Devices and Radiological Health<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Today, the FDA issued a final guidance document titled&nbsp;General Wellness: Policy for Low-Risk Devices. The guidance explains that the FDA does not intend to actively regulate low-risk technologies that are intended only for general wellness use.&nbsp; The FDA encourages the development of general wellness technologies, such as fitness trackers or mobile apps, which can empower [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":335,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[8,9],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CDRH Industry: Announcing the General Wellness: Policy for Low-Risk Devices Final Guidance and Webinar on September 1, 2016 - A Wright Path | Right Path. 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