jueves, 20 de agosto de 2015

CDRH Industry: Correction - Medical Device Export Certificates: Revised FDA Fees

This email is to advise you of a correction to the Aug. 18 email you received regarding revised fees for medical device export certificates. We incorrectly identified that this is the first time the FDA has changed these fees since 1996. This is the second revision to these fees; the first time was in February 2003. We apologize for any confusion.

Original FDA message from August 18, 2015:
Today the FDA issued a Federal Register (FR) Notice announcing revised fees for medical device export certificates that will go into effect on September 1, 2015. This is the first second time the FDA has changed the fees for these certificates since the start of the export certification program in 1996.
Since the last fee change in February 2003, the FDA's costs to process medical device export certificates have increased. Because of this, the agency is revising the formula used to calculate the number of original and subsequent device export certificates issued and raising the fee for subsequent certificates. These changes are necessary to ensure that the program remains self-sustaining.
More information about exporting medical devices and the fees for export certificates for all FDA-regulated products are available on the FDA’s website.

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