MDDI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

FDA’s Registration List is Changing. Should You Be on It?

On August 2, 2012, FDA sent an open letter to the medical device industry advising the industry of significant changes to the establishment registration process. According to the agency, these changes are being driven by the FDA Safety and Innovation Act (FDASIA).

FDASIA was signed into law on July 9, 2012. This piece of legislation grants FDA the authority to collect user fees from industry to fund reviews of drugs, devices, and biologics. The changes to establishment registration went into effect on October 1, the beginning of the government’s fiscal year 2013. As a result of the changes to the establishment registration process, Title 21 CFR Part 807 has been revised. One of the salient changes influencing the device industry is the need for all registered medical device establishments to pay an annual registration fee—not just device manufacturers. The expanded scope, associated with the change in establishment registration, results in establishments previously not required to pay fees such as contract manufacturers and sterilization facilities to file and pay the annual establishment registration fee.

Summary of Changes to the Medical Device Establishment Database

Important Links for Medical Device Establishments

 
 
 
 
 
 

In August, FDA published to the Federal Register a requirement that medical device manufacturers, contract sterilizers, and contract manufacturers are now required to register their products electronically. Medical device establishments, as of October 1, 2012, must register devices on the FDA Unified Registration and Listing System (FURLS). Device manufacturers (foreign and domestic) should establish an account on the FURLS. The FURLS will be employed to update information regarding device establishment registrations and information pertaining to device listings. According to FDA, existing product listing from device manufacturers will be migrated into the FURLS.

As mentioned in the introduction, the expanded requirement for contract manufacturers and contract sterilizers results in establishments falling within these two categories to register and pay the annual establishment registration fees. The requirement applies to domestic and foreign establishments. Another significant regulatory change impacting the device industry is the requirement for contract manufacturers and contract sterilizers to collect and list client devices. Additional changes that went into effect on October 1 are as follows:

  • Proprietary device names that are employed to market a device must be listed.
  • Combination devices, devices employing a device and a biologic or drug component, must be listed as such.
  • Device importers are required to identify the manufacturers of devices they import.
  • Foreign establishments exporting devices into the United States must identify all of the known importers of their devices.
  • Devices are now required to be listed by the: (a) manufacturer; (b) specification developer; (c) device reprocessors; (d) remanufacturers; (e) device repackers; and (f) device relabelers; before listing by foreign exporters; contract manufacturers, or contract sterilizers.
  • Establishments dedicated to complaint management that were previously registered as manufacturers and specification developers, must change their establishment type to Complaint File Establishment (reference 21 CFR Part 820.198).
  • Establishments located in foreign trade zones are now required to register and list their devices. They must clearly identify themselves as residing in a foreign trade zone.
  • All establishments, required to register under these changes, must now pay the annual registration fee (per FDASIA).

Tables 1 (Domestic) and 2 (Foreign) contains specific establishment registration details associated with the changes going into effect on October 1st.

Table I. Requirements for domestic registration and listing by establishments:

Establishment Type: Domestic

Requirements for Fiscal Year 2013

All Establishments

Pay the annual registration user fee prior to registration.
All Establishments, Except Initial Importers

 

Identify all proprietary names for each device listed. Names may be marked as confidential to exclude them from the data published on the FDA web site if disclosure could identify confidential business relationship(s).
Proprietary names may be uploaded from Excel spreadsheets rather than manually typed, if preferred.
Identify combination products and the type of combination product (e.g., device/drug, device/biologic) during listing.
Initial Importers Identify manufacturers of products being imported. This may be done by listing number or searching and identifying the manufacturer in FURLS.
Contract Manufacturers
 
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, list only after the manufacturer, specification developer, single use device remanufacturer or remanufacturer has done so.
Contract Sterilizers
 
Register and list, regardless of whether the contract sterilizer puts the device into commercial distribution or returns the device to their customer.
For nonexempt device, list only after the manufacturer, specification developer, single use device remanufacturer or remanufacturer has done so.

Manufacturers, Specification Developers, Single Use Device Manufacturers, Remanufacturers,
Relabelers

For nonexempt devices, list prior to contract manufacturer or sterilizer, if one is used.
Complaint File Establishment Register and list as a new establishment type and identify facility who maintains complaint files only (per 21 CFR 820.198).
Establishments Located in Foreign Trade Zones
 
Register and list.
Identify the establishment as located in a foreign trade zone.
 

Table 2. Requirements for foreign registration and listing by establishment type:

Establishment Type: Foreign

Requirements for Fiscal Year 2013

All Establishments

 

Identify all proprietary names for each device listed. Names may be marked as confidential to exclude them from the data published on the FDA web site if disclosure could identify confidential business relationship(s). Proprietary names may be uploaded from Excel spreadsheets rather than manually typed, if preferred.
Identify combination products and the type of combination product (e.g., device/drug, device/biologic) during listing.
Identify 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.

Manufacturers, Specification Developers, Single Use Device Manufacturers, Remanufacturers, Relabelers

For non-exempt devices, list prior to contract manufacturer or sterilizer, if one is used.
Complaint File Establishment Register and list as a new establishment type and identify facility who maintains complaint files only (per 21 CFR 820.198).
Contract Manufacturers For nonexempt devices, list only after the manufacturer, specification developer, single-use device remanufacturer or remanufacturer has done so.
Contract Sterilizers For non exempt devices, list only after the manufacturer, specification developer, single-use device remanufacturer or remanufacturer has done so.

 

Impact on the Medical Device Industry

Effective October 1, 2012, all registered medical device establishments are required to pay an annual registration fee. The fee for FY 2013 is $2,575.00. Medical device establishments have until December 31, 2012 to register their establishments and pay the 2013 registration fees. FDA estimates that this revised requirement will result in the addition of approximately 750 contract manufacturers being required to register with the agency. 

For contract manufacturers and sterilizers located outside of the United States and not having a business address within the United States, these foreign entities are required to contract with an agent located within the United States. The US agent must have a valid business address (note: a post-office box is not acceptable). US agents have no adverse event reporting responsibilities, in accordance with 21 CFR Part 803. Additionally, foreign establishments must identify all importers of their devices.   

According to FDA, on February 1, 2012, the agency reached an agreement in principle, with the medical device industry. A draft of MDUFA III was posted on FDA’s website. The 30-day review and comment period ended in April. In July, congress passed legislation allowing MDUFA III to become law, thereby sparing layoffs imminent at FDA had this legislation not passed. Considering the budgetary challenges of the federal government, and the need to reduce federal deficits, FDA badly needed the increase in fees and the expansion of establishments required to pay fees to offset part of the agency’s FY 2013 requested budget of $4.5 billion. According to the initial draft proposal from FDA, the device establishment user fee changes would result in an increase from 16,000 to approximately 22,000 establishments required to register and pay the $2,575 registration fee. This should result in the collection of approximately $57 million to support FDA operational expenses. Some of this addition funding will be used to add FDA headcount (projected 196 FTEs) to improve the agency’s efficiency. These resources will be used to improve the current device application review process and hopefully, a reduction in review times.

Conclusion

Effective October 1, 2012, changes to facility medical device establishment registration requirements will result in a significant expansion of organizations (worldwide) required to register with the agency. Establishments will be required to pay fees, register, and list products on the FURLS prior to December 31, 2012. The expansion of the establishment registration process will result in approximately $57M in registration fees collected by the agency. These fees are needed to support ongoing operations at the agency, including improvements to the device review process. It is the hope of the medical device industry, the addition of FDA headcount will result in a substantial improvement of the application review times, especially review times associated with Class II devices (510(k)). Device establishments that fall under the regulatory umbrella of FDA must visit the FDA’s website and learn as much as possible about these significant changes. One final note: for establishments failing to register and pay establishment registration fees prior to December 31, 2012, these establishments risk delisting by FDA. 

 
++++++++++++
Bob Mehta is principal consultant of GMP ISO Expert Services, a Los Angeles/Orange County-based consulting firm specializing in global supplier quality management, supporting quality systems for FDA and ISO regulated companies and helping with remediation of quality systems as a result of FDA’s warning letters to make the system compliant to regulatory requirements. Mehta has more than 22 years of experience in the fields of quality, regulatory compliance, regulatory and notified body inspections, supply management, and risk management. Mehta holds MSQA, MBA, B.S. (Chem), and ASQ - CSSBB, CQE, CRE, CSQE, CBA, CQA, CPA certifications. He serves on the committee of the Industry Board of Advisor for Medical Device Industry Education Consortium (MDIEC). He is heavily involved in remediating and implementing the risk-based quality systems and supplier audit program for Fortune 500 clients in a variety of industries, including medical device, pharmaceutical, biotech and neutraceutical. 

 

 

500 characters remaining