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Substantial Increase in Registration Fee for Medical Device Facilities

Wednesday, August 30, 2017
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has increased the fee for medical device facility registrations by 37 percent for fiscal year 2018.

Owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, must register annually with the FDA and pay a fee. For FY 2018, which starts Oct. 1, the FDA is increasing this fee from $3,382 to $4,624. There are no fee waivers or reductions for small establishments, businesses, or groups.

Most establishments required to register must also list the devices they make and the activities performed on those devices at that establishment. If a device requires premarket approval or notification before being marketed in the U.S., the owner/operator should also provide the FDA premarket submission number.

The medical device facility registration period will be open Oct. 1 through Dec. 31. Sandler, Travis & Rosenberg’s FDA Solutions Group offers registration and other related services. For more information, please contact Shelly Garg at (305) 894-1043.

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