The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012.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
MD&DI Articles on Home Use FDA Draft Guidance & Be Aware
This post deals with the FDA’s Draft Guidance on Home Use Devices. But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for
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 Extends Comment Period on 510(k) Guidance
On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October
FDA Issues Draft Guidance doc on Mobile “App’s”
On July 21, 2011 the FDA released a draft Guidance document on Mobile “App’s”. There is a 90 day period to submit comments for consideration. (See details on web link for draft guidance). The draft guidance document states in section