FDA Raises Fees for Medical Device Export Certificates

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.

FDA medical device export certificate fee increase 2015The 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).

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