President Barack Obama signed the FDA Safety and Innovation Act on Monday, reauthorizing the agency and doubling the charge devicemakers will pay for approvals over the next 5 years. The charge comes with the promise of FDA reform, and, at least for now, device groups are optimistic for the future.
The bill sailed through Congress after months of negotiation between the industry and the FDA, and the final text will increase the cost to device firms from $295 million over the last 5 years, to $595 million over the next. In exchange, the FDA has agreed to implement a more predictable, reliable, efficient and expeditious approval process for devices.
By and large, the industry has supported the new terms, and trade groups hailed Obama's signing of the bill. Gail Rodriguez, executive director of the Medical Imaging & Technology Alliance, said in a statement that the organization is grateful to Congress and the president for putting aside partisanship to pass a law that will "foster the development of innovative technologies." And Stephen Ubl, CEO of AdvaMed, has said the bill's quick trip through Washington is a sign that industry and government can work together toward a common goal.
Some watchdog groups, however, are less enthusiastic. Consumers Union, for instance, had lobbied for a stricter 510(k) clearance process, requiring devicemakers to prove they fixed any design flaws when trying to market a device based on one that was recalled. Such language was left out of the final bill.