Medical Device Link.

Originally Published MDDI December 2004

EDITOR'S PAGE

Devices are different, CDRH director Daniel Schultz told attendees at the MD&M Minneapolis conference in October. “Devices are a group of varied products,” he said. “FDA’s regulatory system must match that diversity.” Noting such developments as computers that can be swallowed, Schultz said, “This is where the action is.”

And, he said, with the advent of drug-eluting stents and other combination products, devices will soon no longer be just devices. “The line will disappear between drugs, devices, and biologics.”

With the blurring of that line, Schultz said, FDA needs new mechanisms to address these new products. Early interaction with FDA is critical for the changing industry.

Schultz noted that FDA’s performance with PMA review times suffered during the mid-1990s and early 2000s. “We don’t want to go back,” he said. “We want to expedite PMAs of combination products.”

Schultz said the agency’s hope is to move toward “real-time supplements” so that progress is not interrupted. “The modular PMA program would allow companies to send information as it is available,” he said. “The reviewer can review the data over time without compromising safety and effectiveness.”

Schultz said FDA would like to eliminate the “middle step” of the deficiency letter to enable a 180-day, one-cycle review time for devices. “We have a responsibility to work with industry to make [a shorter review cycle] happen,” he said. “We will need more than one cycle for some products, but most will fit into one cycle.”

FDA’s performance goals, he said, include meeting with companies up front, developing modular PMAs, and issuing guidances. FDA’s goal is to hit a target of approving 90% of its PMAs within 320 days by 2007. “Guidance documents are critical to meeting these goals,” Schultz said.

He noted, however, that even with modular PMAs and one-cycle reviews, problems could still arise. “FDA needs to get out and do inspections. The field force did more inspections in 2004 than anticipated, but we are still far from meeting our statutory requirements. The truth is, we are never going to get there. And, it’s not just that we need to do more; we need to do better.”

Schultz said FDA’s aim is to align its resources with patient risk. Long-term safety, he said, will have to be looked at throughout the product life cycle. “We want to speed products to market without compromising safety and efficacy.”

He said, too, that implementing a strong postmarket program would help shift some of the burden away from FDA’s premarket group. “Many approval studies are ill-conceived, and FDA is not good at tracking and enforcement.”

Better postmarket study design is essential. A better balance of pre- and postmarket requirements ultimately would free FDA’s ODE staff to focus more on premarket reviews. Improved postmarket studies would also generate data for enhanced labeling. Such data could also be used to develop the next generation of products. It is essential that FDA take the steps necessary to ensure that it keeps up with the changing device industry.

The Editors

Copyright ©2004 Medical Device & Diagnostic Industry