The FDA has announced an increase in fees for assessing and exporting medical devices.
The FDA Export Reform and Enhancement Act of 1996 enables manufacturers to request that the FDA issue a certification stating that their device meets certain requirements within 20 days. It also allows the FDA to charge up to $175 for each original certification.
On September 1st, 2015 the new fees for subsequent certificates will be raised from the current cost of $15 to $85 and a new formula to calculate exportation fees will be implemented.
The FDA lists three recoverable cost categories for issuing export certificates:
- Direct personnel for research, review, tracking, writing and assembly
- purchase of equipment and supplies used for tracking, processing, printing and packaging
- billing and collection of fees
- overhead and administrative support
Requests for medical device exportation documents have doubled over the last 10 years. As medical device regulation is still developing, the raised fees are attributed to a rise in demands of such certifications and higher payroll costs (FDA).
Related article: How the 4.2% Medical Device User Fee Increase Impacts You