CDRH updates at Convergence: COVID-19 and ISO 13485

Regulatory NewsRegulatory News | 15 September 2020 |  By 

Top officials from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) responded to questions raised during the CDRH Forum at RAPS Convergence 2020 on Tuesday.
Opening the forum, CDRH Director Jeff Shuren said that one of CDRH’s priorities will be to determine how it can carry forward some of the flexibilities it has embraced during the coronavirus disease (COVID-19) pandemic.
“The greatest tragedy of the pandemic would be if we did not learn from it, and not just how we can be better prepared for the next outbreak, but how we can take the lessons learned and better serve patients at all times,” Shuren said.
On transitioning out of pandemic-mode, Shuren said that CDRH is planning to issue draft guidance to clear up questions related to products being used either under emergency use authorizations (EUAs) or one of the agency’s enforcement discretion policies.
“Our goal is to provide predictability and sufficient time to transition, but we’ll put that out as a draft guidance and seek public comment before we finalize any of our plans. We’re not anticipating any big changes any time soon,” he added.
Timothy Stenzel, director of CDRH’s Office of In Vitro Diagnostics and Radiological Health, also clarified that FDA’s practice has not been to immediately remove products authorized under EUAs from the market after the public health emergency phase has ended and once products have begun to receive full authorization. “The past cannot necessarily predict the future [but] we still have tests that are authorized for Zika, enterovirus, Ebola, the 2013 coronavirus [MERS], the 2013 H7N9 [influenza],” he said.
Stenzel shared some of the changes his office has embraced and how those changes may continue beyond the pandemic. “Necessity is the mother of invention,” he said. “We have now started to authorize a lot of self-collection, home-collection [tests] to meet the pandemic needs. We’ve gotten more and more comfortable about patients doing more … and I think that’s going to expand as we move out of this pandemic.”
Stenzel also said he has found virtual meetings to be very efficient. “I don’t know that I’ve found that sponsors and developers have been disadvantaged [by them] in any way. I can go from one meeting to the next in 30 seconds versus if I was in the building it would take more than that to move from one floor or office to another.” Stenzel said this has allowed his staff to spend more time in meetings “dealing with important topics.”
William Maisel, director of the Office of Product Evaluation and Quality at CDRH, noted that CDRH is still prioritizing its COVID-related work. “The public health issues always take priority,” he said. “We are then prioritizing our statutory deadlines and [Medical Device User Fee Amendments] MDUFA work, and then other things are on a time-available basis,” he said, noting that the center is prioritizing submissions and that the center’s ability to meet MDUFA deadlines related to presubmissions “is definitely strained.”
ISO 13485:2016
Medical device companies that have been eagerly awaiting news on FDA’s plans to harmonize its Quality System Regulation (QSR) with the widely used international standard ISO 13485:2016 will need to wait just a bit longer, Shuren announced.
FDA first said it plans to align more closely with ISO 13485 in 2018 but has since delayed issuing a proposed rule on the transition multiple times. In its most recent unified agenda, the agency said it would issue the proposed rule sometime in October.
“This remains a high priority for the center, but as you can imagine with all the attention we’ve had to focus on COVID-19, there are many other activities we could not devote the same level of engagement on. So, we anticipate that it will be a little while longer before we’re able to issue the ISO 13485 regulation,” Shuren said.
Shuren also reassured the audience that companies will have plenty of notice ahead of any transition to the new regulation.
“In terms of implementation, just keep in mind that we will allow time for transition, but at the point we put out a proposed rule we still have to get public comment, review it, and put out a final rule. So you’ll see in a proposed rule what we would plan to do and that should be a starting point for folks to begin to make appropriate changes,” Shuren said.
Shuren noted that FDA will articulate any differences between ISO 13485 “and how we’ll address them from the US perspective.”
RAPS Convergence 2020


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