FDA Industry Letter for Medical Device Establishments Issued

The FDA’s Center for Devices and Radiological Health (CDRH) has issued an industry letter reminding all medical device establishments that for fiscal year (FY) 2013, beginning October 1, 2012, all establishments, foreign and domestic, must pay the annual registration user fee, regardless of their establishment type or activities conducted. Medical device companies pay user fees to the FDA when they register their establishment and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the United States, and for certain other types of submissions. The user fee for FY 2013 is $2,575. This industry letter also details several additional requirements effective for FY 2013 based on whether the establishment is foreign or domestic. 

Domestic Establishment Requirements

All domestic establishments, except initial importers, must identify:

  •  (1) all proprietary names for each device listed, and
  •  (2) combination products and the type of combination product (e.g., device/drug, device/biologic) during listing.

Initial importers must identify manufacturers of products being imported by listing number or searching and identifying the manufacturer in the FDA’s Unified Registration and Listing System (FURLS). 

Domestic contract manufacturers and contract sterilizers must register and list, regardless of whether the contract manufacturer puts the device into commercial distribution or returns the device to their customer. For non-exempt devices, however, they must list only after the manufacturer, specification developer, single-use device remanufacturer or remanufacturer has done so.

Domestic establishments located in a foreign trade zone must register, list, and identify the establishment as located in a foreign trade zone.

Foreign Establishment Requirements

All foreign establishments must identify:

  • (1) all proprietary names for each device listed;
  • (2) combination products and the type of combination product (e.g., device/drug, device/biologic) during listing; and
  • (3) all importers known to the foreign establishment, including agents, brokers, or other parties used by the foreign establishment to facilitate the import of its device into the United States.

For non-exempt devices, foreign contract manufacturers and sterilizers must list only after the manufacturer, specification developer, single-use device remanufacturer or remanufacturer has done so.

Foreign and Domestic Establishment Requirements

For non-exempt devices, foreign and domestic manufacturers, specification developers, single-use device manufacturers, remanufacturers, and re-labelers must list prior to the contract manufacturer or sterilizer, if one is used.

All foreign and domestic establishments must register and list as a new establishment type and identify the facility who maintains complaint files only per 21 CFR §820.198.

Key 2012 Legislative and Regulatory Actions.

The FDA Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, includes the Medical Device User Fee Amendments of 2012 (MDUFA III) as well as other medical device provisions. MDUFA III mandates that an annual registration user fee be paid for all types of establishments.

In response to MDUFA III, on August 1, 2012, FDA revised 21 CFR Part 807 to reflect the statutory amendments to the medical device registration and listing provisions. The amendments require domestic and foreign device establishments to submit their registration and device listing information electronically via the FDA’s FURLS Device Registration and Listing Module (DRLM) and specify the timeframes for submitting such information.