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COVID-19: What CDRH Wants You to Know about Regulatory Submissions and Clinical Trials

Last updated: 4/6/2020

FDA’s Center for Devices and Radiological Health (CDRH) continues to issue letters to industry regarding what to expect as companies and the agency respond to the COVID-19 pandemic. The agency has prioritized the advancement of the U.S. government’s and private sector’s response to address the impact of COVID-19, while trying to maintain normal operations. 

Its recent letter outlines how to proceed, whether you work directly with virus-response products or not. (You can review FDA's growing list of COVID-19-related guidance online.)

Communications: Meetings and Documents

Where possible, CDRH will host teleconferences rather than in-person meetings with industry through April 30, 2020, sticking to the same date and time as the previously-scheduled physical meeting.

The Document Control Center continues to receive and process incoming documents, but generally not via email. Other electronic options are being sought out by the agency.

Submission Extensions

If any of your applications are on hold as of March 16 with a response-due date by June 30, CDRH will give you a 90-day extension for your 510(k), Premarket Approval/PMA app (original and supplements), Humanitarian Device Exemption app (same) and De Novo classification requests. This will be done automatically—there’s no need to ask for one. (This was updated from the previous extension of 60 days for a response-due date by April 30.)

For additional submission types where a response or report is due (e.g., Post Approval or 522 Study reports, Investigational Device Exemption annual reports, PMA reports), you’re encouraged to submit the response or report when possible.

What About Clinical Trials? What About Inspections?

In a separate communication, FDA issued nonbinding recommendations for ways to best prepare for and mitigate the effects of COVID-19 on clinical trials and to help assure the safety of trial participants, maintain compliance with good clinical practice and minimize risks to trial integrity during the pandemic.

Considerations include, but aren’t limited to:

  • Making decisions regarding continuing trial recruitment, continuing use of an investigational product for patients already participating in the trial, and the need to change patient monitoring during the trial
  • Determinations regarding the possible use of alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative locations like local labs or imaging centers) when necessary and feasible
  • The possibility that it may be appropriate to delay some assessments for ongoing trials, or, if the study cannot be properly conducted under the existing protocol, decide whether to stop ongoing recruitment or even withdraw trial participants

Regarding inspections, in other separate communications, FDA noted that it has halted most foreign inspections through April and has temporarily postponed all domestic routine surveillance facility inspections.

The Highest Priority

In sum, CDRH continues to work on mission critical postmarket and compliance activities. In closure of his letter on March 23, Dr. William Maisel, Director, Office of Product Evaluation and Quality, said, “Medical devices play an essential role in advancing public health in the response to the COVID-19 national emergency. As such, our work in supporting the availability of critically-needed medical devices is our highest priority.”


 
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