Jul 1, 2020

The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time.

New guidance from FDA explains the regulator’s approach to conducting premarket medical device reviews, adjusting user fees and consulting with manufacturers during the COVID-19 crisis. Given FDA’s ongoing work on Emergency Use Authorizations (EUAs) for ventilators, IVD test kits and other medical equipment in high demand, the guidance states that some performance goals and user fee commitments established under MDUFA IV may be missed or delayed. Furthermore, US medical device market registrants should expect greater use of video- and teleconferencing when meeting with FDA officials for 510(k) premarket notifications, Premarket Approvals (PMA) or Q-Submission consultations.

FDA premarket review, Q-sub meetings go virtual

FDA’s Center for Devices and Radiological Health (CDRH) now hosts teleconferences rather than in-person meetings with medical device and IVD companies; all requests from industry for in-person meetings will be processed as requests for teleconference meetings, according to the guidance.

Applicants may continue to request Q-submission consultations with FDA, to be conducted via teleconference or written responses from the agency.

Regarding advisory committee meetings, FDA plans virtual meetings, as well.

Effects of COVID-19 work on MDUFA performance goals

As FDA’s work on EUAs and related efforts to fight COVID-19, agency resources have had to be reallocated and reassigned, which may mean that “it is possible that we will not be able to sustain our current performance levels indefinitely,” the guidance states.

  • In the event that a MDUFA performance goal pertaining to a premarket submission  is not met, FDA will initiate procedures for missed MDUFA decisions as applicable for 510(k), PMA and/or De Novo submissions.
  • The agency will follow similar procedures in the event that MDUFA goal dates regarding user fees are missed.
  • Regarding premarket submissions currently on hold at FDA as of March 16, 2020, the agency will grant an additional 90 days for applicants to respond to deficiency letters:
    • PMAs and Humanitarian Device Exemption submissions: from 360 days to 450 days
    • 510(k) and De Novo request submissions: from 180 days to 270 days

Bottom line: Potential delays for non-EUA premarket reviews?

Based on the new FDA guidance, US market applicants whose devices do not target COVID-19 may face delayed premarket review timeframes as the agency allocates internal resources to EUA designations and other pandemic-related activities.

Learn more about US FDA medical device regulations at Emergo by UL:

  • US FDA 510(k) consulting for medical device and IVD manufacturers
  • FDA Emergency Use Authorization (EUA) pathway for medical devices and IVDs
  • Whitepaper: Early communication with US FDA

 

 

Author

  • Stewart Eisenhart

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