For Medical Devices
FDA Postponing Annual Registration of Medical Device Establishments
FDA is postponing the annual registration of registered medical device establishments, pending changes planned for the fourth quarter of 2007.
The FDA announced in June that it is postponing the annual registration of registered medical device companies for 2008.
FDA expects to resume annual registrations in October or November 2007. If a company is registered for 2007, that registration will remain valid until December 31, 2007.
In a letter to owners and operators of registered medical device companies, FDA outlined the following reasons for the delay:
1. Electronic registration and listing. Section 510(p) of the Federal Food, Drug, and Cosmetic Act permits FDA to require registration of medical device establishments “by electronic means” once FDA has determined “the electronic receipt of such registrations is feasible.” FDA will soon announce that they have made that determination. They are preparing to complete and publish
a proposed regulation to implement electronic registration of medical device establishments and electronic listing of the medical devices that are produced or processed by those establishments. Electronic registration and listing will benefit both FDA and medical device companies because:
- It will be quicker and easier. It will avoid mistakes (which currently occur about 1/3 of the time), because error-checking is built in.
- The enhanced accuracy and accessibility of the system will allow FDA to reduce a company’s mandatory review and update of listing information to just once a year, instead of twice. This change will require Congressional approval, and FDA expects it will be among the statutory changes Congress will consider later this year.
- Establishments will no longer have to research and enter product code information for nonexempt medical devices, because the electronic system will provide the correct product codes automatically.
- Companies will have 24/7 access to update or make changes on their own schedule.
- The electronic system will allow listing of more than one proprietary name for a given product.
- Improved accuracy and timeliness will make a company’s listing data more useful to hospitals, health care professionals, and others who are trying to find sources for particular types of devices.
2. Simpler registration and listing requirements. In conjunction with FDA’s planned transition to electronic registration and listing, it is working to complete a proposed revision of its regulations governing medical device establishment registration and medical device listing, 21 C.F.R. Part 807. They expect this revision will make their requirements easier to understand, and will provide medical device companies greater flexibility in describing the devices they list. Companies will have an opportunity to provide comments and suggestions later this year when FDA formally proposes these changes in a Federal Register notice.
3. FDA will implement the Bioterrorism Act. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188, the “Bioterrorism Act”) requires each foreign establishment to provide, as part of its registration, the name of each known importer of the establishment's devices and the name of each person who imports or offers to import the device into
the United States. FDA’s revision of its registration and listing regulations will help foreign establishments meet this statutory requirement.
4. Congress will consider new legislation that may affect registration and listing. As directed by section 105 of the Medical Device User Fee and Modernization Act of 2002, FDA is actively developing recommendations to the Congress for the goals and plans for the process for the review of medical device applications beginning fiscal year 2008, and for the reauthorization of the user fee sections of the Federal Food, Drug, and Cosmetic Act. As an essential part of this process, FDA is consulting with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry. Although those consultations are still underway, FDA expects some of its recommendations to Congress, if adopted, may affect the medical device registration and listing requirements.
FDA’s move to electronic registration is ground-breaking for the government agency. “Historically in the medical device side of FDA, everything has always been done on paper,” says Matt Lowe, medical device product manager for MasterControl. “FDA will provide the electronic registration system for medical device companies. In the past, they’ve always provided a paper form, so this is a significant change in procedure for them.”
“I think the FDA recognizes the benefit of moving to electronic systems,” he continues. “Electronic systems will make the registration process much easier for everyone involved. It looks like the paper registration process is going away. It may also signal a move by the agency to shift more and more processes away from paper and over to electronic processes.”
An FDA official says Congress is still debating the electronic registration issue. “In the meantime, if firms have changes in data, they can continue making those changes using the paper-based system. We hope that by October 1, we’ll know what decision Congress has made, according to the law. We assume we’ll be accepting some kind of registrations after October 1 but we’re unsure as to what format they’ll take. In the meantime, we’ll be prepared to take care of everyone, no matter what happens.”
Medical device manufacturers with questions should call (240) 276-0111 or send an email to email@example.com.
Read more about FDA documentation: