March 18, 2010 – Medical Device Today
Article reprinted from “The Gray Sheet” – March 15, 2010
FDA is exploring ways to inform industry of changes to its regulatory expectations more quickly than guidance documents or standards development allow, device center director Jeffrey Shuren said last week.
The center is trying to determine when and how to update manufacturers on revisions to standards for getting a new product to market, Shuren explained March 10 at the annual standards and regulation conference hosted by FDA and the Association for the Advancement of Medical Instrumentation (AAMI).
“We may say, ‘We expect a change in design, we may expect a change in how that product is assessed,'” Shuren said. “Well, every time we make that decision, if you’ve got a device in the works, you are going to have to make a change.”
Requiring these changes on an ad hoc, case-by-case basis does not benefit device makers, Shuren said, acknowledging longstanding industry concerns.
But the guidance development process can be slow and requires “a lot of resources,” he noted.
“One of the things we’re thinking is, are there other mechanisms by which we can convey our expectations in a more timely manner, and can we be a little bit more predictable about when our expectations change?” he told conference attendees.
Guidance Development: A Cumbersome Process
Maggie Dietrich, special assistant to Shuren, also pointed out that writing guidance documents, one of FDA’s key methods of communication, is “a very cumbersome process.”
The device industry prefers guidance development, with the industry input it entails, as a way to communicate changes in regulatory expectations. But companies agree that it is important to communicate requirements “as quickly as possible,” Janet Trunzo, executive VP of technology and regulatory affairs at AdvaMed, said in an interview.
“If FDA believes that the guidance document process and internal review process at FDA takes too long, FDA could at least communicate through stakeholder meetings … or perhaps issuing points to consider or the outline of the guidance it is thinking of developing,” Trunzo said.
FDA has already taken steps to improve other early communications tools, such as public health notifications, over the past years, Dietrich said at the FDA/AAMI conference.
“We put out early communications where there’s a concern for us but we’re not quite sure what to do with it, but we want to get people’s attentions to make sure that they understand the state of our current knowledge,” she said.
But AdvaMed has voiced some concerns with this approach.
In February comments to FDA on the issue of incorporating new science into regulatory decisions, the association said the agency has failed in the past to discuss issues involved in public health notifications with all relevant stakeholders, such as device firms or clinicians, leading to “biased notices.”
CDRH Plans Continuum Of Communications
Shuren suggested that companies consider quicker communications tools as part of a continuum.
“We may have a tool by which we say, ‘In this case, here’s what we’re thinking now,’ and we’ll do it fast,” he said. “We might then move to a guidance to provide more details. And then we may still be working on a standard to ultimately put out.”
He pointed to the center’s recent initiative on reducing unnecessary radiation exposure during medical imaging procedures, which involves an FDA white paper, a public meeting this month and, eventually, new rulemaking and guidance (The Gray Sheet’ Feb. 15, 2010).
FDA’s communications overhaul is part of the device center’s broader work to increase transparency, which is a strategic priority for 2010 (The Gray Sheet’ Jan. 25, 2010).
According to a priorities report issued in January, CDRH plans to implement a “strategic communication program” by the end of September.
– Jessica Bylander