This post deals with the FDA’s Draft Guidance on Home Use Devices. But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for
FDA on Quest to Standardize Mandatory MedDvc Labeling
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
FDA Issues Draft Guidance on MedDvcs Intended for Home Use
On 12 December 2012 the FDA issued a new Draft Guidance for Industry & FDA Staff on Design Considerations (for design and development) for Devices Intended for Home Use.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
GHTF has transitioned to IMDRF
As of November 2012 the GHTF (Global Harmonization Task Force) is no longer operating as evidenced by several pieces of information. In it’s place the International Medical Device Regulators Forum (IMDRF) is working to “build on the strong foundation of
L. Eisner Talk 13 Dec on IEC 60601-1, 3rd ed. – US, EU, Japan, Brazil, & Canada National Implementation
Leo Eisner will be speaking on “IEC 60601–1, 3rd Edition – Where Do We Stand on National Implementation?” via FX Conferences on Dec 13, 2012 at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). He will be discussing the National