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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told attendees at the final session at AdvaMed’s MedTech conference in San Jose, California, that his center is plotting the creation of a new "super office."
The so-called "Total Product Life Cycle 'Super' Office" will integrate premarket, postmarket surveillance and quality-compliance functions, Shuren said, noting it will be "a big deal."
The office will reorganize "CDRH to better support CDRH employees in achieving our public health mission and their professional development," Shuren added.
CDRH chief scientist William Maisel also told attendees: "Nothing is drastically changing right now, but we need to improve efficiency and make decisions faster and reduce decision time."
Shuren added that the new structure "will help in terms of what we bring to the table around a product – where we have to bring in multiple offices, we’ll reduce inefficiencies. Some of the things we may build out will be related to combination products" and streamlining their reviews.
In addition to the new super office, Shuren also mentioned that there are discussions underway around the creation of an "alternative 510(k) pathway," which would "reduce uncertainty, streamline 510(k)s and facilitate international harmonization."
Shuren added that FDA is looking at this alternative pathway as a possible legislative change, though time ran out when the agency tried to add it to the recently passed user fee reauthorization package.
He also spoke to the agency’s increasingly flexible regulatory paradigm whereby FDA has deregulated in areas where oversight might not add value, such as with medical software. In terms of flexibility, he singled out the agency’s push to accept less premarket data in favor of more postmarket data, the increasing use of real-world evidence, the enhanced use of consensus standards and the agency’s "Case for Quality" initiative.
In an earlier conference session on Wednesday, Maisel also highlighted a four-fold increase in the approval of novel devices between 2009 and 2016, as well as a 90% reduction in time to investigational device exemption approval from 2011 to 2016.
Tags: postapproval, 510(k) pathway, medical device approvals, total product life cycle super office