COVID-19 – Guidance on Formal Meetings and User Fee Applications

Due to the COVID-19 public health emergency, the FDA has released a new guidance document titled “Effects of the COIVD-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices – Questions and Answers.” The reason for this guidance is to address the frequently asked questions about policy and regulatory issues that apply to the development of devices for the duration of this public health emergency. The FDA recognizes the effects COVID-19 has had on the development of devices. Additionally, the agency recognizes that applicants and submitters have many regulatory questions related to these effects.

Meetings with Industry

Q1. What specific plans does FDA have in place to hold previously scheduled meetings associated with submission or application reviews and/or timelines?

FDA is leveraging technology to host teleconferences and videoconferences rather than in-person meetings with industry during the COVID-19 public health emergency. Until further notice, all requests for in-person meetings will be handled as requests for teleconferences, and all CDRH meetings previously scheduled as in-person meetings have been converted to teleconferences to be held at the same date and time. CBER may use teleconference or videoconference meeting formats.

Q2. As submitters and applicants continue to submit Q-submission requests, what are FDA’s plans to accept new Q-submission requests and provide submitters or applicants with options for alternative meeting formats?

FDA is continuing to accept new Q-submission requests. Q-submission requests for CDRH meetings are currently being scheduled as teleconference meetings or, when requested by the sponsor, FDA is providing a written response only.

Q3. Does FDA plan to conduct upcoming advisory committee meetings virtually?

FDA is continuing to evaluate the feasibility of conducting advisory committee meetings virtually. We believe we can host advisory committee meetings virtually with current technology. The CDRH OHTs and CBER Offices will work closely with submitters and applicants for specific submissions or applications that could potentially be affected and will discuss options for pursuing teleconference or videoconference (live virtual) meetings.

MDUFA Goals and Timelines

Q4. Will some MDUFA submissions or applications be delayed because of the COVID-19 public health emergency?

FDA remains committed to the Medical Device User Fee Amendments (MDUFA) performance goals. However, we are experiencing considerable increases in COVID-19 activities related to pre-Emergency Use Authorizations (pre-EUAs), EUAs, and the development of policies, requiring shifting of staff resources to focus on these critical activities. The COVID19 public health emergency also has other effects on our resources such as deployments of staff who are members of the U.S. Public Health Service Commissioned Corps. With many staff members working on COVID-19 activities and activities with statutory deadlines, it is possible that we will not be able to sustain our current performance levels indefinitely.

Q5. Will the goal dates be extended because of the COVID-19 public health emergency?

We are committed to working to meet the performance goals outlined in the MDUFA commitment letter. However, with many staff members working on COVID-19 activities and activities with statutory deadlines, we may not be able to maintain our current level of performance with respect to the performance goals and associated timelines in our user fee commitments. The MDUFA commitment letter does not contemplate FDA extending or changing user fee goal dates, except in certain instances like following submission of an unsolicited major amendment that would allow for a clock extension. If FDA anticipates missing a MDUFA goal date because of the current public health emergency, we plan to communicate with the submitter or applicant directly.

Q6. What is FDA’s policy for marketing submissions or applications currently on hold?

For marketing submissions or applications on hold, FDA generally considers the submission or application to be withdrawn if the submitter or applicant does not provide a complete response to major deficiency letters for PMA (original and supplements) and Humanitarian Device Exemption (HDE) applications (original and supplements) within 360 days or to additional information letters for 510(k)s and De Novos requests within 180 days. Given the COVID19 public health emergency, we recognize that applicants may face challenges affecting their ability to meet their applicable response date, and FDA may be unable to process a high volume of individual extension requests on a timely basis.

Q7. In the event that Biologics License Application (BLA) goal dates for devices licensed under the Public Health Service Act are not able to be met because of the COVID-19 public health emergency, how will CBER communicate these missed dates to applicants?

As with other products subject to MDUFA, we are committed to working to meet the performance goals outlined in the MDUFA commitment letter for BLA devices. However, with many staff members working on COVID-19 activities, we may not be able to maintain our level of performance with respect to the performance goals and associated timelines in our user fee commitments. Should a device regulated by CBER as a biological product under Section 351 of the PHS Act miss its MDUFA performance goal, CBER will communicate with the submitter or applicant directly.

Q8. What additional guidance has FDA provided about COVID-19?

The FDA has issued additional immediately in effect guidance documents related to COVID-19. For the latest information, please see FDA’s COVID-19 Related Guidance Documents web page.

For the full update to all questions and answers, as well as access to additional resources, please visit the guidance document’s webpage.

mdi Consultants can assist your company with any further questions you may have by emailing [email protected] RE: COVID19.