|Regulations & Standards|
Originally Published January 2000
Device reforms at CBER: Enough or too much?
FDA's Center for Biologics Evaluation and Research (CBER) has finally embarked upon a long-range plan to modernize the ways in which it reviews premarket submissions for medical devices. Whatever benefits may come from such a plan, it is still worth asking why CBER is spending its limited time and resources reviewing medical device marketing applications.
Under the terms of a 1991 intercenter agreement with the Center for Devices and Radiological Health (CDRH), CBER has the lead responsibility for regulating medical devices—including cellular biologicals—used in the "collection, processing, storage, or administration" of blood products. CBER is also responsible for ensuring that screening and in vitro tests used by blood banks meet appropriate standards. Finally, CBER regulates all in vitro tests or other medical devices intended to diagnose or otherwise address the human immu-nodeficiency virus (HIV) and other retroviruses.
According to recent CBER data, the biologics center clears or approves approximately 60 premarket submissions (510(k)s) or premarket approval (PMA) applications per year, totaling 65 submissions in fiscal 1998. By contrast, CDRH clears or approves in the neighborhood of 10,000 submissions per year, totaling 10,455 submissions in fiscal 1998.
The CBER annual report for fiscal 1998 is curiously silent about the length of time the center spends reviewing device submissions. However, data from fiscal 1997 indicate that CBER took an average of 360 days to clear a 510(k), as opposed to the average of 130 days spent by CDRH on each 510(k) submission.
Such statistics suggest that CBER's move to modernize its handling of device submissions is long overdue. However, it is questionable whether CBER's new Device Action Plan is the proper or necessary vehicle for ensuring that the center can keep up with the rapid pace of innovation in the device industry.
The CBER Plan
CBER's Device Action Plan speaks primarily of ensuring consistent application of regulatory requirements, enhancing communication with industry, and identifying problems in the management and processing of device submissions. All of these are laudatory goals, but they are also objectives that CDRH began tackling five years ago.
CDRH has made great headway in reengineering its internal processes and implementing the improvements mandated by the FDA Modernization Act of 1997, but it is still struggling to meet the review time frames set forth by law. This ongoing task is the same job that CBER is insisting on duplicating for the handful of devices it reviews each year.
While senior FDA officials complain publicly about the limited resources available for conducting their regulatory and public-health missions, these same officials apparently support spending thousands of staff hours and untold dollars to enable CBER to reinvent a wheel that its sister agency has spent the past five years modernizing. Simply put, going through such major motions in the hope of speeding the review of a mere 60 devices per year is a colossal misallocation of human and financial resources.
On several occasions the Medical Device Manufacturers Association (MDMA) has urged CBER to return to CDRH the lead authority for reviewing the medical devices currently under its jurisdiction. It is not known whether CBER has ever seriously considered this recommendation. However, the introduction to the center's Device Action Plan argues somewhat defensively that "CBER has developed specific expertise in blood, blood products, and cellular therapies, and the integral association of certain medical devices with those biological products supports the regulation of those devices by CBER."
Safe, Pure, and Potent
Granted, CBER has the authority, under delegation from the secretary of Health and Human Services, to regulate biological products. However, the secretary did not specifically delegate to CBER the authority to regulate the devices associated with such products. The terms of the 1991 intercenter agreement provide CBER with the authority to regulate such associated devices as plasmapheresis machines, in vitro reagents used in processing licensed biologicals, and software for clinical laboratory devices used in blood banks.
CBER tends to review such medical devices as though they were biologicals. However, the statutory requirements for regulating biologicals are very different from those for regulating devices. Biologicals are regulated under the Public Health Service Act, which directs the secretary to determine whether a biological product is safe, pure, potent, and manufactured accordingly before granting a license. Devices are regulated under the Federal Food, Drug, and Cosmetic Act, which directs the secretary to determine whether there is reasonable assurance that a device is safe and effective before granting marketing approval.
The devices associated with biologicals do not differ enough from other nontherapeutic devices regulated by CDRH to justify CBER's continued authority over them. Although CBER has the authority to license blood banks and plasmapheresis centers where such devices are generally used, the relevant question that CBER asks—are these devices safe and effective for their intended use?—is the same question that CDRH asks. MDMA therefore believes that CDRH has the ability to determine whether such devices are safe and effective or substantially equivalent to a predicate device. Moreover, CDRH currently has the necessary processes in place to make such determinations more efficiently than CBER can.
CBER officials should recognize that it will require considerable time and effort to replicate the reengineering that CDRH has pioneered. Whether CBER will also be able to develop a regulatory approach that distinguishes the legal standards for regulating biologicals from those for regulating devices is another question entirely. But if CBER continues to treat 510(k)s and PMAs as though they were biologics license applications (BLAs), all of the reengineering proposed in the Device Action Plan will be pointless.
Rather than asking CBER to continue reviewing products under two different statutory schemes, CBER and CDRH should revisit the 1991 intercenter agreement and return to CDRH the authority for regulating medical devices associated with biologicals. CBER would then be able to focus its limited resources on its core missions of regulating biological products and the nation's blood supply, while CDRH would review the safety and effectiveness of the related medical devices—a task that is well within the device center's core competency.
Americans insist that the federal government ensure the safety of the nation's blood supply. At the same time, however, Americans know that companies in our industry are working every day to develop devices that hold the promise of screening, processing, and storing blood more safely, and they want to see these products brought to market with all deliberate speed.
Striking the proper balance between the potential risks and benefits of medical technologies, within the guidelines of the law, is ultimately FDA's responsibility. Whether CBER is the most appropriate agency to strike the critical balance in this instance is a question that should be asked by both industry and society at large.
Stephen Northrup is executive director of the Medical Device Manufacturers Association (Washington, DC).