FDA raises fees for medical device export certificates

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has revised fees the agency charges for issuing medical device export certificates in response to higher costs and demands for these documents.

The new fees go into effect September 1, 2015. From that date on, the FDA will use a new formula to calculate export certificate fees; the agency may charge up to $175 for original certificates, while subsequent certificates requested for the same device will cost $85.

Fees for medical device export certificates have not increased since 2003, according to the FDA, but the volume of certificates requested has more than doubled between 2003 (25,236 certificates) and 2014 (52,193 certificates).

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

The post FDA raises fees for medical device export certificates appeared first on MassDevice.

from MassDevice http://ift.tt/1J6kXQ6