Eisner Safety Consultants

On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October 25, 2011 to November 28, 2011. In the Federal Register Notice the FDA said “The [...]

Come join Eisner Safety Consultants at one or both conferences March 3 & 4th.  Both are related to the 60601 series of standards. On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information [...]

How to comment on FDA CDRH FY11 Draft Guidance Documents? http://ht.ly/2OiXg From the FDA CDRH webpage titled “Documents the CDRH is Considering for Development (FY11)” the following is the intoduction to the page: “This is the list of guidance documents CDRH is considering for development this year (2011). CDRH plans to update this list every [...]

Comment on Draft Guidance for Industry, 3rd Parties & FDA Staff: ISO 13485:2003 Voluntary Audit Rprt Submission Program http://ht.ly/1OeVB

Draft FDA Guidance – Infusion Pumps – Total Product Life Cycle – Premarket Notification [510(k)] Submissions http://ow.ly/1EjNL