Medical Device Contract Manufacturers and Contract Sterilizers Now Required to Register and List
Establishments involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the U.S. Food and Drug Administration (“FDA“). 21 C.F.R. § 807.20. Most establishments are also required to list the devices that are made at their facilities and the activities that are performed on those devices. Id. The process is known as establishment registration and listing. Those firms required to register and list are also required to pay the associated user fee.
Effective October 1, 2012, the requirements for medical device establishment registration and listing will change. On August 2, 2012, the FDA issued “Medical Device Establishment Registration and Listing – Notice of Changes for FY 2013” and a final rule to implement the requirements enacted in Section 321 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Act“), and Section 207 of the Medical Device User Fee and Modernization Act (“MDUFMA“). The notice and final rule require all registered medical device establishments to pay the annual registration fee, regardless of the type or activities conducted. In addition, certain establishments must comply with additional registration and listing requirements.
The most notable change contained in the final rule requires all contract manufacturers and contract sterilizers to register the devices they manufacture and sterilize with the FDA. Previously, contract manufacturers and contract sterilizers were exempt from registration and listing requirements pursuant to 21 C.F.R. 807.20(c)(1)-(2). However, the final rule eliminates the exemption for contract manufacturers and contract sterilizers, thus requiring those who were previously exempt to register, list, and pay the user fee. This change significantly expands the scope of establishments subject to the annual establishment registration and listing requirements. As a result, the FDA estimates that the new rule will increase the number of establishments paying the user fee from 16,000 to 22,000.
Other changes to medical device registration and listing requirements resulting from this new final rule include:
- All registration and listing submissions must be made to the FDA through electronic means rather than paper forms;
- Foreign establishments must identify all known importers and the name of each person who imports or offers to import the foreign establishments device into the United States; and
- All establishments must pay a registration fee when they initially register with the FDA and for each annual registration thereafter.
On September 12, 2012, the FDA released a document entitled “Frequently Asked Questions about the New Device Registration and Listing Requirements.” The list of FAQs is designed to assist medical device establishments with under the new registration and listing requirements. The FAQs address issues such as: updating existing registration information, proprietary (brand) names, combination products, medical device excise tax, foreign establishments, exporters, importers, and contract manufacturers and sterilizers.
An establishments failure to register and list as required by the final rule will cause the firms medical device to be deemed to be misbranded by the FDA pursuant to 21 U.S.C. § 352(o). Thus, establishments should ensure that they properly register and list with the FDA.
For information on how Fuerst Ittleman David & Joseph PL can assist your firm with registering and listing your medical device with the FDA pursuant to the new requirements, please contact us at contact@fidjlaw.com.