{"id":571,"date":"2016-01-25T19:46:26","date_gmt":"2016-01-25T19:46:26","guid":{"rendered":"https:\/\/awrightpath.net\/?p=571"},"modified":"2019-06-05T19:48:22","modified_gmt":"2019-06-05T19:48:22","slug":"announcing-draft-guidance-on-interoperable-medical-devices","status":"publish","type":"post","link":"https:\/\/awrightpath.net\/announcing-draft-guidance-on-interoperable-medical-devices\/","title":{"rendered":"Announcing Draft Guidance on Interoperable Medical Devices"},"content":{"rendered":"\n<p>Today, the FDA issued draft guidance:<a href=\"http:\/\/www.fda.gov\/ucm\/groups\/fdagov-public\/%40fdagov-meddev-gen\/documents\/document\/ucm482649.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">&nbsp;Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices<\/a>&nbsp;to provide clarity on how the agency evaluates medical devices that electronically connect and interact with other devices or systems. This guidance provides manufacturers with design considerations for developing interoperable medical devices and recommendations on information to include in pre-market submissions and device labeling.<\/p>\n\n\n\n<p>Interoperability refers to the ability of medical devices to interact with other medical devices and systems, including electronic health record systems, and to communicate with each other using a common vocabulary. Connecting interoperable medical devices can improve the efficiency of health care through means such as automatically populating an electronic health record or allowing doctors to monitor their patients remotely to make treatment decisions without physically being in the hospital.<\/p>\n\n\n\n<p>The FDA believes that the use and development of standards that support interoperability of medical devices is vital to creating interoperable systems that are reliable and safe.<\/p>\n\n\n\n<p>We welcome your comments and suggestions regarding this draft guidance. Submit comments to&nbsp;<a href=\"http:\/\/www.regulations.gov\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.regulations.gov<\/a>, using the docket number FDA-2016-01471.<\/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Today, the FDA issued draft guidance:&nbsp;Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices&nbsp;to provide clarity on how the agency evaluates medical devices that electronically connect and interact with other devices or systems. This guidance provides manufacturers with design considerations for developing interoperable medical devices and recommendations on information to include in pre-market submissions [&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>Announcing Draft Guidance on Interoperable Medical Devices - A Wright Path | Right Path. 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