FDA Final Rule Mandates Electronic Registration of Device Establishments
Posted 01 August 2012 | By
The US Food and Drug Administration (FDA) has issued a final rule regarding electronic device registration and listing requirements, putting into practice a long-awaited rule combining the requirements of several pieces of legislation with a newly-revamped digital registration system.
In its 1 August Federal Register posting, FDA said the regulation requires domestic and foreign medical device establishments to register with the agency electronically and will "improve the quality of registration and listing information available to FDA."
Agency officials wrote the regulation wraps up the requirements of three distinct pieces of legislation, all of which established various requirements for registering devices. The FDA Amendments Act of 2007, for example, requires electronic registration by domestic manufacturing facilities, while the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires the same of foreign establishments. Elements of the Medical Device User Fee and Modernization Act of 2002 are also included in the bill, FDA said, though it did not explain which ones.
In the same posting, FDA said it had originally delayed the implementation of such a system because it had until now been unable to create a system to receive the registrations. Such a system is now in place in the form of a 2007 system known as the Unified Registration and Listing System (FURLS), the agency said. FDA will still be authorized to grant waiver requests, it added.
"FDA believes this electronic system will ultimately make the process of submitting registration and listing information for devices more efficient for industry and will provide faster access to this information for both FDA and industry," wrote FDA in the posting. "In addition, the new electronic system will allow FDA to more effectively gather information concerning marketed devices. We rely on having complete and accurate registration and listing information to accomplish a number of important statutory and regulatory objectives."
The objectives include identifying establishments, identifying device shortages and the source of problematic products, facilitating recalls, conducting postmarketing surveillance and identifying violators of federal law.
Changes under the Rule
Under the new rule, Implementation of Device Registration and Listing Requirements, all owners or operators of medical device establishments will be required to register electronically with the agency through the FURLS system. All information submitted to the agency prior to September 2007 is already populated in the new system, FDA explained.
Other formerly exempt entities such as contract sterilizers and contract manufacturers will also be required to register under the new rule, which FDA said will assist it in its ability to have a "complete and accurate registration of device establishments and listing information for devices…to accomplish regulatory objectives."
Foreign establishments will be subject to the same requirements, with the added caveat that their devices will not be allowed into the US if their information is not within FDA's FURLS system at the time of import. Foreign establishments will also be required to maintain a list of all approved importers in the US, along with the name of an approved person at each import establishment. FDA noted several exemptions to this rule, including one allowing devices that enter a "foreign trade zone" within the US without entering US markets, will be eliminated under the new regulation.
Domestic establishments, too, will be required to list an official correspondent for the establishment as well as a contact person for the operator or owner of the facility. The contact person "is the only person who can administer the owner or operator's user accounts in FURLS," notes FDA.
The new system also requires manufacturers to list the 510(k) or HDE (Humanitarian Device Exemption) number for their cleared devices along with their establishment listing, giving FDA another tool to, "Help ensure that devices that lack a required premarket clearance or premarket approval are not marketed."
Finally, the rule moves beyond the abstract listings of prior versions and requires companies to identify what, exactly, their establishments do as part of their device listings in FURLS.