Changes in medical device regulations stipulated by the Safe MedicalDevices Act of 1990 will help the Center for Devices and RadiologicalHealth improve the monitoring and control of medical equipment,said James Benson, deputy commissioner of the Food and
Changes in medical device regulations stipulated by the Safe MedicalDevices Act of 1990 will help the Center for Devices and RadiologicalHealth improve the monitoring and control of medical equipment,said James Benson, deputy commissioner of the Food and Drug Administration.But the CDRH will be hard-pressed to back up its new responsibilitieswith sufficient financial and staff resources, he said.
Benson served with the CDRH as deputy director from its inceptionin 1982 until 1989. He will return to the device agency next monthas acting director.
Among the positive changes brought about by the new legislationis codification of the 510(k) product approval process, he said.
"People are concerned about some changes that occurredin the 510(k) process that may make requirements more extensive,"he said. "But they forget that the way 510(k) products werebeing handled was an invention of the old Medical Device Bureau.It was not crisply laid out in law. I was concerned that courtswould overturn the way that process was being handled. We desperatelyneeded a firm statutory base for the 510(k) process, and the newlaw gives us that. That is a terribly important strengtheningof the foundation of the whole medical device scheme."
CDRH staff are working now to interpret the law and generatethe necessary regulations to begin implementation of the deviceact. Existing resources are being switched around within the agencyto accomplish this start-up phase, he said.
"We need to get a lot of regulations out simultaneously,and this will come out of our hide. We will have to take peopleoff jobs they are working on," Benson said.
Over the longer term, however, the center needs to find additionalfunding to adequately follow the regulatory requirements of theact, he said.
"I am concerned about the long-term implications of theneed for resources. We (the CDRH) were already understaffed ina number of areas. We tried hard to make sure products were safeand to put adequate emphasis on enforcement, but we were slippingin terms of field inspections. There is enormous pressure fromindustry to keep the approval process rolling. Unfortunately,it will cost on the order of 300 person-years to implement thenew legislation. We are going to have to look to future budgetyears to deal with that," Benson told SCAN.
One additional source of funds examined repeatedly in the pastbut never implemented is charging companies user fees when theirproducts are reviewed.
"We have included user fees for a number of years as partof our budget submission. But Congress has always seen fit toappropriate (funds) without user fees. My view is that we needto work with the industry to figure out the right formula. Sooneror later, user fees are going to become a necessity," Bensonsaid.
The device act requires distributors and users to report adverseequipment incidents to the FDA. Distributor reporting should nothave a significant impact on the agency, Benson said.
"User reporting, on the other hand, is a controversialarea of the bill and one we did not support. It will have a majorimpact on hospitals and physicians and on us in terms of the numberof reports," he said.
The CDRH is concerned about all equipment performance and safetyproblems. However, no one is helped if the center becomes so inundatedwith report data that it can't adequately review the information,Benson said.