Recognized Consensus Standard Database – Eisner Safety Consultants

FDA Finally Adds to Fall 2020 Recognized Consensus Standards db for Cycle Update

Updated 22 Dec 2020 – In the last couple of years, the FDA has started to post the standards updates on their Recognized Consensus Standards db prior to publishing in the Federal Register (FR). This year, being the year we

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 Especially since the draft guidance has been pushed forward and then pushed back aside so many times internally at FDA it is really hard to

FDA Extends AAMI ES 60601-1 Transition Date to 31 Dec ’13 & Other Important Changes – Recognition Lists 031/032

The big news in the IEC 60601-1, 3rd ed. world today is the US National Standard that is in the FDA’s Recognized Consensus Standards Lists [Now is ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) – Recognition List #:

Med Electronic Dvc Soln’s Trade Pub’ed Article by Leo Eisner on FDA Home Use Draft Guidance Doc

The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012.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MD&DI Articles on Home Use FDA Draft Guidance & Be Aware

This post deals with the FDA’s Draft Guidance on Home Use Devices. But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for

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