Shuren updates on inspections, ISO 13485 and MDUFA V

Regulatory NewsRegulatory News | 10 May 2021 |  By 

Long delayed — even before the COVID-19 pandemic — the US Food and Drug Administration’s (FDA) proposed rule to harmonize its medical device Quality System Regulation (QSR) with the international standard, ISO 13485:2016, may finally see the light of day this year.
The much-anticipated proposed rule has been on FDA’s regulatory agenda for several years, and despite COVID-related delays, it is back on track, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH) said at the FDA/Xavier MedCon conference last Thursday.
FDA staff are “moving forward and we’re making great progress” on the proposed rule, as well as guidance on medical device remanufacturing, Shuren said. While the goal is to get the proposed rule this year, Shuren refused to offer a more specific timeline. “I don’t have a crystal ball on timing simply because a lot of it is out of our hands, but our goal is it will happen this year,” he said.
Shuren also elaborated on why the rule has been held up for so long. “We want to make sure we do it right and have done the right crosswalk in terms of what we have and what we have already with QSR and the standard … Secondly, we got hit by COVID. That’s the reality of it and folks who were engaged in the regulation had COVID duties and COVID is top priority.”
One of the Center’s other top priorities in the near term will be issuing two draft guidances laying out the path for transitioning devices and tests being used under emergency use authorizations (EUAs) to full marketing authorizations and how the agency will handle products marketed under its temporary enforcement policies. Shuren said the guidance will be issued as drafts to give people the opportunity to comment and that the transition will allow companies time to comply.
Shuren also said that FDA is looking to expand its ability to monitor medical device shortages, building on new authorities granted to the agency during public health emergencies under the CARES Act last year.
“Congress gave us some limited authorities that only kick in once a public health emergency declared, so kind of too little too late, at least better than nothing. This is something that we’re talking to authorizers about, assuring that we’ve got a good window to what’s happening in the supply chain,” he said.
While the pandemic has had a dramatic impact on the agency’s ability to conduct inspections, Shuren said that it has compensated by leveraging the Medical Device Single Audit Program (MDSAP) and more recently by conducting voluntary remote regulatory assessments.
Since February, the Office of Regulatory Affairs (ORA) has performed about 50 remote regulatory assessments.
“They’re voluntary, they’re not a true inspection, but [they] can get important information,” Shuren said, adding that the agency is keen to get feedback from participating companies. Shuren also said the agency is pursuing other tools and mechanisms for remote interactions and that he envisions such tools and the Center’s new Customer Collaboration Portal as key to enabling virtual interactions in a hybrid world.
Shuren also touched on FDA’s resiliency roadmap for inspectional oversight and the new Inspectional Affairs Council announced alongside it on Wednesday and said it is “anticipated we will have senior-level folks from across the agency participating.” (RELATED: FDA tallies pandemic inspection toll, issues new 'resiliency roadmap', Regulatory Focus 5 May 2021).
With the agency in the midst of negotiations to reauthorize the Medical Device User Fee Amendments (MDUFA), Shuren said the pandemic is continuing to impact review performance.
(RELATED: MDUFA V: Industry wants fine tuning while FDA seeks expansion, Regulatory Focus 27 October 2020; MDUFA V: Deficiency letters, staffing and funding emerge as issues in early negotiations, Regulatory Focus 20 April 2021).
“We are starting to see an impact on our review times for the very first time in many years, starting to see some fall off in review times for 510(k)s and also on [premarket approvals] PMAs,” “We’re doing our best to try to keep things on track, but it is possible we might to start to see an impact on our MDUFA performance goals out of the submission we received in 2020,” he said.
Looking forward to MDUFA V, Shuren said FDA would like to see the program broadened to include more postmarket components.
“Unlike the drug program, the device program is more narrow in scope and this is really the time to have the conversation about should MDUFA really be broader in scope and we start bringing under its tent some of the postmarket safety activity,” Shuren said.
With the program’s current focus centered on premarket reviews, Shuren said that a total product lifecycle approach would help bring more value to patients.
Shuren also said he would like to see more resources under MDUFA for early evaluation and validation activities. “We’ve got pre-subs, but they’re under resourced, quite frankly. They’re very formal and there’s a longer timeframe before those formal meetings can happen.” Even with breakthrough devices, “we’re not well-resourced for them and we’ve got a number of cases where we can’t do what we’d like to do,” due to resource constraints.


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