October Monthly Topic:
The FDA Amendments Act of 2007:
Reauthorization of the Medical Device User Fee Program
and Other Key Provisions
On September 27, 2007, President Bush signed into law the FDA Amendments Act (“the Amendments”), which includes, among other things, the reauthorization of the medical device user fee program that was originally established under the Medical Device User Fee and Modernization Act (“MDUFMA”) of 2002. The Amendments also include additional changes to the user fee program, authorize the agency to implement an electronic registration system for medical device companies, and grant the authority to FDA to establish a unique identifier system for medical devices. As discussed below, new provisions to the Federal Food, Drug and Cosmetic Act (“FDCA” or “the Act”) enhance the development of pediatric medical devices, establish a new framework for clinical trial registries, and place new restrictions on members of FDA advisory panels in an effort to address conflicts of interest.
Medical Device User Fees. Paramount to the medical device industry, the Amendments reauthorize and modify the existing user fee program, allowing the agency to collect $287 million in industry fees to help fund premarket review activities through 2012. Although the Amendments lower premarket submission fees, four new categories of fees have been included. One of these is an annual registration fee for all device manufacturers. Up until now, FDA has not required medical device manufacturers to pay an annual registration fee. The Center for Devices and Radiological Health (“CDRH”) has drafted letters explaining the new fee and the mandatory electronic registration process, which will be mailed to every currently registered company. Additionally, CDRH will post the information on its registration and listings web page.
The additional revenues generated from fees paid by the medical device industry are intended to expedite the medical device review process in accordance with performance goals established by FDA in consultation with industry. To this end, an interactive review process has been established. This process formally allows FDA reviewers to contact a company directly with questions about that company’s PMA or 510(k). The hope is that this policy will reduce the number of major deficiency letters issued and give companies a chance to clear up any deficiencies in a more efficient manner. This approach is expected to save time and resources by preventing applications from being placed on hold for significant periods of time. A guidance document discussing FDA’s new policy is expected to be published by December 27, 2007.
Annual Establishment Registration and Listing. The Amendments also modify the schedule for the annual establishment registration for medical device companies. Specifically, annual registration will take place between October 1 and December 31. In addition, listing of medical devices will be required at the same time as annual registration and must include updated lists of a company’s products sold in the U.S. The Amendments also authorize FDA to require that all medical device company registration and device listings be submitted electronically in the absence of a waiver.
Electronic MDRs. The Amendments establish an electronic Medical Device Reporting (“eMDR”) process intended to help CDRH more easily identify patterns of adverse events related to medical devices. FDA is urging device manufacturers to voluntarily adopt the agency’s eMDR process in anticipation of being required to do so next spring. A draft rule, which will make the currently optional program mandatory, is expected to be released for public comment in February 2008. The device center intends to move forward quickly with the new rule, which is expected to reduce the expense associated with manually entering adverse events into FDA’s database.
Clinical Trial Registry. The Amendments include a provision requiring device companies to register their clinical trials with a National Institutes of Health (“NIH”) database. The NIH database—which will list descriptive information, such as study design and purpose, outcome measures, and recruitment information—will be publicly available on the Internet. Congress is currently drafting technical amendments to provide further instruction regarding the specifics of this program, including the incorporation of adverse event information. As such, additional information will be provided as it becomes available.
Unique Device Identifiers. The Amendments contain provisions granting FDA the express authority to propose and ultimately implement regulations requiring medical devices to display a unique identifier. The unique identifier must adequately identify the device through distribution and use and may include information on the lot or serial number. The specifics of this program have not yet been determined. FDA has been directed to define and promulgate the program through notice-and-comment rulemaking.
Pediatric Medical Device Safety and Improvement Act. The Amendments seek to increase the availability of pediatric devices. To this end, adult data may now be used to determine device effectiveness in pediatric populations if the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients. Accordingly, it may not be necessary to conduct separate studies in each pediatric subpopulation—such as neonates, infants, children, and adolescents—if data from one subpopulation can be effectively extrapolated to another. As a safety measure, FDA is authorized to issue postmarket surveillance orders for class II and class III devices that are expected to have “significant” use in pediatric populations. If necessary to assess the impact of the device on growth and development, or safety and efficacy, prospective surveillance periods of more than 36 months may be ordered.
The Amendments also permit manufacturers of a pediatric device receiving a Humanitarian Device Exemption (“HDE”) to sell their device for profit, provided that the device meets all other HDE requirements. However, the number of devices distributed during a year may not exceed the annual distribution number specified by FDA when the HDE was granted. The Amendments require FDA to issue a guidance document for institutional review committees explaining how to evaluate requests for HDE approvals. In addition, the General Accountability Office (“GAO”) is required to report to Congress with an assessment of the impact of this exemption scheme no later than January 2012.
Pediatric medical device research and development is to be expanded under the Amendments per a plan to be submitted by the Secretary addressing: (1) the current status of federally funded pediatric medical research; (2) a research agenda to improve development of pediatric medical devices; (3) a strategy for obtaining clearance or approval of such devices through FDA; and (4) an evaluation of the short- and long-term effectiveness of such devices. Federal funds will be distributed through grants or contracts awarded to nonprofit organizations for projects that promote pediatric device development by encouraging innovation in pediatric devices, connect industry members and physicians to manufactures or other resources, and provide assistance and advice on pre- and postmarket needs for such devices.
Conflicts of Interest. The Amendments establish new rules to address potential conflicts of interest involving members of FDA advisory panels. To this end, the Secretary must determine the number of waivers granted in 2007 as a percentage of the total number of committee members. This percentage will be used as the baseline waiver ratio, which must be reduced by 5% each year for the next five years. Under the Amendments, when a committee member has a conflict of interest with respect to a particular matter before the committee, that member may not participate in the discussion or vote held on the matter, unless a waiver of the conflict is granted by the Secretary. The scope of the conflict-waiver can be narrow, allowing only participation in panel meetings or hearings, or broad, allowing the member to vote. Each conflict must be disclosed on the FDA website, along with a notice describing the conflict. If a waiver is granted, the reasons for granting any waiver will be included as part of the public record.