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Presentation on Navigating FDA’s Home Use Medical Devices Draft Guidance

Leo Eisner will be presenting on the topic “Navigating FDA’s Draft Guidance on Home Use Medical Devices” at an FX Conferences event on 11 July, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern).  You don’t have to leave your office to join in on the presentation and as a special thank you for […]

Med Electronic Dvc Soln’s Trade Pub’ed Article by Leo Eisner on FDA Home Use Draft Guidance Doc

The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012.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that the Medical Electronic Device Solutions (MEDS) Trade Publication released on February 2013 is titled FDA Issues Draft Guidance on Medical Devices Intended for Home Use.

Which 60601-1, 3rd ed. Standard Applicable for FDA?

I have been asked in a variety of flavors if 3rd ed. of IEC 60601-1:2005 and/or 3rd ed. + Amendment 1 (A1):2012 will be required by the FDA and when? The answer isn’t exactly yes or no.  The end of the transition period for 2nd ed. of IEC 60601-1 is June 30, 2013.  By July […]

MD&DI Articles on Home Use FDA Draft Guidance & Be Aware

This post deals with the FDA’s Draft Guidance on Home Use Devices.  But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for 1 deal).  The MD&DI Editor-in-Chief, Heather Thompson, wrote two articles on the FDA Home Use Draft […]

FDA Issues Draft Guidance on MedDvcs Intended for Home Use

On 12 December 2012 the FDA issued a new Draft Guidance for Industry & FDA Staff on Design Considerations (for design and development) for Devices Intended for Home Use. Back in April 2010 the FDA launched the Medical Device Home Use Initiative as there were concerns of the growing number of safety issues with medical […]