US FDA to Require Proof of IEC 60601-1 3rd Edition in Summer 2013

The US Food and Drug Administration will begin requiring manufacturers and sponsors of electrical medical devices to show compliance with the standard ES 60601 3rd Edition starting June 30, 2013.

This means that the US regulator will no longer accept IEC/ES 60601 2nd Edition compliance in 510(k) premarket notification applications, premarket approval (PMA) submissions or other US FDA medical device registrations. Manufacturers’ design controls and quality management systems will also have to show proof of compliance with IEC 60601 3rd Edition starting June 30th.

Any manufacturers whose medical device registration in the US currently includes IEC 60601 2nd Edition compliance should prepare for compliance with the latest edition of the standard if they haven’t already done so.

Update: The FDA will require IEC 60601 3rd Edition testing for new devices following the June 2013 deadline. Manufacturers of devices that have already been cleared or approved for sale in the US will have to assess their device changes and cumulative design changes in order to comply with the IEC standard's latest iteration.

Stewart Eisenhart

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