The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012.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
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
Proposal for FDA Create New Office to Regulate Mobile Apps
11 Feb 2013 – Regulatory Focus (RAPS) News Article indicates that there will be a re-introduced proposal going thru the US Congress, sometime this year, for the FDA’s CDRH to create a new office to Regulate Mobile Medical Device Applications. What
IEC TR 62348:2012 Added in Assessment of impact of most significant changes of IEC 60601-1:2005 Amendment 1
A very useful document was recently released to be a summary of the significant and moderate changes made to IEC 60601-1:2005 based on Amendment 1 (A1) of IEC 60601-1. This is an excellent resource (IEC TR 62348:2012, published 12 Dec
EU MDD, AIMDD, IVDD Harmonized Standards (EN980 & EN ISO 15223-1) Ooopppss!
The EN 980 Symbols for use in the labeling of medical devices standard was mistakenly taken off of the EU Harmonized List of standards on the Jan 24, ’13 release and EN ISO 15223-1 Medical devices — Symbols to be