Eisner Safety Consultants

Eisner Safety Consultants Newsletter #5 Now Online
This issue we are going to focus on primarily on IEC/EN 60601-1:2005/2006 as there is some significant news within the last few weeks and more to come really soon.  Also, we would be remiss if we didn’t remind you that the MDD Amendment 2007/47/EC becomes mandatory this weekend on [...]

March 18, 2010 – Medical Device Today
Article reprinted from “The Gray Sheet” – March 15, 2010
FDA is exploring ways to inform industry of changes to its regulatory expectations more quickly than guidance documents or standards development allow, device center director Jeffrey Shuren said last week.

Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications
A draft guidance has been issued for comment purposes only, see “Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications” issued March 13, 2009, which if issued as final, will replace the currently available guidance which was [...]