Guidance documents to help you determine if your Wearable device is a medical device that needs FDA approval or not for US submissions. Wearables may be the rage but what does your company need to do for an FDA medical
IEC 60601-1-2:2014 (4th ed.) What is the Impact of this Puzzle on Your Product Design?
This is a summary of some of the changes in EMC requirements of IEC 60601-1-2, 4th ed. & a discussion of timing of requirements in different world regions. Darryl Ray, of Darryl Ray EMC Consulting, provided the technical and regulatory
Can an OSHA NRTL Certify to ANSI/AAMI ES60601-1:2005/(R)2012 with Amendments Yet?
This article discusses OSHA’s release of ANSI/AAMI ES60601-1:2005/(R)2012 + Amendments & timing of @ least 1 NRTL’s authorization to use it. On 27 March 2014 OSHA announced thru a Federal Register Final Notice that they are incorporating new test standards
IEC 60601-1-2, 4th ed. (Electromagnetic disturbances in M.E.E. Environment) recently published
The fourth edition of IEC 60601-1-2 was published on 25 February 2014. It constitutes a significant change in the standard from the third edition of the standard which was published back in 2007.
When will FDA Issue Guidance Document on AAMI ES 60601-1, 3rd ed. + Amendment 1?
That’s a really good question and the answer is sooner than I would have thought. Especially since the draft guidance has been pushed forward and then pushed back aside so many times internally at FDA it is really hard to