The U.S. Food and Drug Administration (FDA) has extended the registration renewal deadline for medical device establishments from Dec. 31, 2012 to Jan. 31, 2013. In addition, FDA has been drastically overloaded and delayed in responding to communications from the extra MDUFA III requirements this year and is asking industry to allow two weeks for responses. FDA is also rolling out a new online registration and listing platform.
Background
The Food and Drug Administration Safety and Innovation Act (FDASIA), passed in July 2012, is intended to help increase FDA’s efficiency and effectiveness in regulating medical products on the U.S. market. FDASIA addresses several categories of medical products, including medical devices, generic and prescription drugs, and pediatric medicine and research.
The amendments set forth in the Medical Device User Fee Act (MDUFA III), one of the subsections of FDASIA, went into effect October 1, 2012. MDUFA III added several requirements to the previous MDUFA, most notably requiring medical device importers to pay the FDA User Fees at registration and requiring foreign manufacturers to disclose their U.S. importers on their establishment registrations.
FDA’s regulations regarding drugs are so stringent that they effectively suppress any “grey market” in imported drugs – bypassing the authorized dealer by importing a product from a third party not in the country of origin, for a lower price. FDA prevents this kind of dealing in drugs because it is difficult or impossible to track their storing and processing, and therefore FDA cannot ensure their safety and effectiveness. The addition of the new MDUFA III registration requirements for medical device manufacturers may provide FDA with a regulatory method for preventing “grey market” dealing in medical devices, for similar reasons. Since, at the time of registration, manufacturers now list importers and importers list manufacturers, FDA will have the ability to identify potential grey market devices. Specifically, if a firm not listed among a manufacturer’s importers attempts to import that manufacturer’s products, FDA may conclude that firm might not be a legitimate importer and subject the entry to heightened scrutiny. Whether FDA will take such steps remains to be seen.
MDUFA III also expands the definitions and types of medical device establishments that must pay a registration fee. Now, any facility that registers must pay the registration fee. This includes:
New registrants:
- Domestic Establishments
- Contract manufacturers
- Contract sterilizers
- Complaint file establishment
- Establishments located in Foreign Trade Zones
- Foreign Establishments
- Complaint file establishment
FDA predicts that these user fee changes will provide the resources it needs for a more efficient medical device review process (which can currently take several months – sometimes even years) as well as allow FDA to develop guidance documents and increase communication related to the submission and review process.
Because MDUFA III mandated several significant new requirements, and did so in such a short time (passed in July 2012 and effective October 2012: allowing industry only three months to come into compliance), FDA has extended the registration renewal period for medical device establishments for this year. Instead of the normal deadline of December 31, 2012, FDA extended the date to January 31, 2013.
Additionally, FDA is updating and enhancing FURLS, the online registration and listing platform, to create a much more user-friendly experience for submitters. The improved platform will support uploading spreadsheets both for declaring importers and for listing proprietary device names.
The most important changes to note in MDUFA III:
- Importers are now required to pay the DFUF registration fee ($2,575.00).
- Foreign manufacturers must disclose U.S. importers for each device.
- All proprietary names must be provided for each device.
Though in the long run these changes are intended to allow to better communication and disclosure, the process of meeting the new requirements can be daunting and complex. The team at FDAImports.com assists medical device manufacturers all over the world with the regulatory expertise needed to succeed.
