FDA Medical Device Facility Registration and Device Listing

FDA Medical Device Facility Registration and Device Listing

Annual Renewal Requirement

FDA medical device facility registration requirements apply to owners or operators of facilities engaged in the manufacturing, packaging, distribution and importation of medical devices intended for use in the United States (U.S.).  Additionally, most medical device establishments that are required to register with the FDA are also required to list the devices they handle at the facility and provide information about the activities that are performed on those devices.

All medical device facilities required to register with the FDA must pay the annual registration, as described in the below schedule:

Year FY 2013 FY 2014 FY 2015 FY 2016 FY 2017
Fee $2,575 $3,313 $3,750 $3,872 $3,872

Medical device facility registrations must be renewed annually during the last quarter of the year (October 1 – December 31) to remain active for the upcoming calendar year.  Failure to timely renew may result in the cancellation of the existing registration number.

To register your medical device facility today, contact Ann Marie Gaitan, Esq. at 786.440.8119 or via e-mail at amg@suarezgaitanlaw.com.

The 2014 renewal period is now open!

Your FDA medical device facility registration will expire on December 31, 2013 if you do not take the necessary steps to renew your registration! To avoid any unnecessary encumbrances on your business, it is recommended that the device establishment renewal and annual fee be filed as soon as possible.

Let Suarez Gaitan renew your medical device facility registration and secure your continued compliance.  To retain our services, please  complete the 2014 Medical Device Facility Registration and Listing renewal questionnaire and return same to our office with payment before December 13, 2013.