The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012. The article that the Medical Electronic Device Solutions (MEDS) Trade Publication released on February 2013 is titled FDA Issues Draft Guidance on Medical Devices Intended for Home Use.
In Addition to this article I have blogged on the topic a couple other times so if you want to see more material (original post) on the topic please continue to read on more of the details and experiences that impact many different people in many different ways (some good and some not so good) on the use of Medical Devices in the Home Use environment and how that impacts the users and their families that use these old and new technologies in the home. Sometime these devices really are only designed for the hospital setting like some IV pumps, patients may have trouble with them to the point that patients pass away, which is a real tragedy no matter how you look at it. There are 2 MD&DI articles on the Home Use Draft Guidance and one of the articles deals with an IV pump that probably shouldn’t have been in the home use environment with really sad results.
If you company needs support dealing with the IEC 60601-1-11 standard for Home Use Environment or with the FDA Home Use Draft Guidance document, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval we can provide you with regulatory, product safety, standards compliance, quality system services and more. Please feel free to contact us at or 503-244-6151.