FDA Consensus Standards – Eisner Safety Consultants

FDA Adds Interpretation Sheet 1 on Essential Performance & SFC of IEC 60601-1 to AAMI ES60601-1 Recognitions DB

The FDA on May 30, 2022, same day as when the recent AAMI 60601 Amendments were Recognized, added the Interpretation Sheet 1 (ISH1) – Amendment 1 – on Essential Performance (Clause 4.3) and Single Fault Condition (Clause 4.7) based on

Med Electronic Dvc Soln’s Trade Pub’ed Article by Leo Eisner on FDA Home Use Draft Guidance Doc

The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012.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

FDA & EU MDD / AIMDD / IVDD Updated Standards Lists

Recently the FDA (United States) has released its latest List of Recognized Consensus Standards & the EU (European Union) has released updated lists of Harmonized Standards for the MDD (Medical Device Directive), the AIMDD (Active Implantable Medical Device Directive), and

MD&DI Articles on Home Use FDA Draft Guidance & Be Aware

This post deals with the FDA’s Draft Guidance on Home Use Devices. But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for