Eisner Safety Consultants

The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012.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that the Medical Electronic Device Solutions (MEDS) Trade Publication released on February 2013 is titled FDA Issues Draft Guidance on Medical Devices Intended for Home Use.

A new LinkedIn group has been formed thx to the support of the IEC (International Electrotechnical Commission)*.  The group name is the IEC 60601 series of standards on Medical Electrical Equipment.  This group is not just about the 3rd edition of IEC 60601-1 but about the whole series of IEC 60601 series of standards and [...]

This post deals with the FDA’s Draft Guidance on Home Use Devices.  But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for 1 deal).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 [...]

On 4 Jan 2013 the FDA issued, in the Federal Register, a notice of Public Workshop entitled “Accessible Standardized Medical Device Labeling”.  FDA indicated the focus of the workshop is to “discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare [...]

On 12 December 2012 the FDA issued a new Draft Guidance for Industry & FDA Staff on Design Considerations (for design and development) for Devices Intended for Home Use.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 [...]