By Jim Dickinson
When FDA’s current regulatory scheme for medical devices was being invented on Capitol Hill in the 1976 Medical Device Amendments, the universal credo was “don’t emulate drug regulation—medical devices are not drugs.”
So a totally different, less prescriptive matrix came into being, the most striking feature of which was section 510(k), under which new medical devices could enter the market without any FDA action at all, simply on the manufacturer’s notification of intent and sufficient documentation to show “substantial equivalence” to an already marketed, and thus grandfathered, pre-1976 device. FDA could disagree for good reason and prevent marketing, but the new matrix assumed this would be a rarity.
Like any new invention, the new regulatory scheme had its teething troubles. Adjusting interpretations were made in the courts and in Congress over the ensuing years, and there were numerous and typically unconfessed administrative abuses.
But always the 1976 Amendments’ defenders kept up the conceptual mantra: “Devices are not drugs.” Whenever CDRH was asked to look over the wall to its sister Center for Drug Evaluation and Research (CDER) for ideas, a negative chorus arose.
Until now. In what some may see as a tacit admission that “regulation lite” has not been a runaway success, FDA commissioner Margaret Hamburg openly acknowledged before a March hearing of the Senate Health, Education, Labor, and Pensions Committee that CDRH is now looking at approval pathways CDER provides to pharmaceutical companies as a means to build new mechanisms to help speed devices to market.
CDRH, Hamburg said, can learn from CDER and “real-world use with postmarket surveillance and collection of data and additional postapproval studies” that could speed devices that meet an unmet medical need to market.
“That has been a theme of the drug side, and it is part of CDRH’s strategic plan as an approach to integrating postmarket studies into the overall assessment and an ongoing understanding,” she said. “We will be eager to work with stakeholders to shape this pathway as we go forward.”
Relying on postmarketing data to speed device approvals is part of CDRH’s proposed Innovation Pathway, a program intended to put pioneering medical devices on the fast-track to review.
“We put out our Innovation Pathway as a way for engaging with the innovators far earlier in the device development in a shared, collaborative way for us to better understand newer technology,” CDRH director Jeffrey Shuren told a recent industry conference.
“When we don’t have a regulatory pathway in place, then let’s try to figure out that pathway together,” he urged. “What we did with the artificial pancreas is a nice example, and you will see more of that coming out in the future... Another innovative move is to also look at the circumstances where we might be able to shift some of the established premarket data needs into the postmarket setting, either through a more formal data collection process or by leveraging the national medical device surveillance system as we start to get that off the ground.”
A draft guidance is planned and CDRH is looking to obtain more stakeholder input on the proposal.
Newly appointed CDRH associate director for technology and innovation Murray Sheldon told a separate conference that the initial approach to implementing the new pathway involves practicing new review concepts without dismantling CDRH’s core review procedures, including the 510(k), IDE and Premarket Application (PMA).
If proven successful, Sheldon said, new review concepts applied to the more innovative products will be expanded to other existing review programs. He noted that experimentation is now underway with innovative reviews of three products intended to treat end-stage renal disease, chosen from among 32 device applicants.
Other Innovation Pathway projects for 2014 include study of ways to streamline clinical trials, ways to streamline approval to reimbursement (in collaboration with Medicare and CMS), and striking the “right” balance between pre- and postmarket evidentiary requirements.
According to Sheldon, an essential aspect of the Innovation Pathway will be to create a “shared view” of what constitutes program—and product—success. He indicated that reviewers must begin to understand the time-cost of different regulatory choices and work with sponsors to create a more collaborative environment.
The use of FDA’s IT Conference Center, which allows conference participants—sponsors and CDRH staff—to meet via Skype for exchange of views, will help foster and maintain “forward momentum” on innovative projects as they move through the development process.
Jim Dickinson is MD+DI's contributing editor.
[image courtesy of MARIN/FREEDIGITALPHOTOS.NET]