The FDA said Monday that it will continue holding formal meetings with device sponsors virtually due to the COVID-19 pandemic for now. The agency also said that it may miss some deadlines in completing user-fee work on premarket device approval applications.
In a Q&A document, the agency said that until further notice, all requests for in-person meetings will be handled as requests for teleconferences. All Center for Devices and Radiological Health (CDRH) meetings previously scheduled as in-person meetings have been converted to teleconferences to be held at the same date and time. The agency said its officials are considering whether to hold advisory meetings virtually and will discuss options for pursuing teleconference or videoconference live virtual meetings with applicants.
In the same document, the agency said that staffers are so busy with COVID-19-related work such as emergency use authorizations and developing emergency-related policies that it may miss some deadlines for medtech applications. They’ve been able to keep up so far and don’t anticipate having to extend or change user-fee goal dates, but will advise applicants directly if it expects to miss a goal, the agency added. Congressionally-authorized user fees provide funding for the review process.
In a separate statement, FDA commissioner Stephen Hahn said the agency anticipates meeting deadlines for marketing applications on medical devices and biologics, “although it is possible that we will not be able to sustain our current level of performance indefinitely.”
The FDA postponed routine foreign inspections beginning in March, based on State Department travel guidance. While “mission-critical” inspections of domestic and foreign manufacturing facilities continued, FDA staffers took a different tack with routine inspections, assessing “records of recent inspections to review the facility’s compliance history, used information shared by foreign regulatory partners through mutual recognition and confidentiality agreements, and conducted reviews of documents typically evaluated on site to assess the processes implemented at the manufacturing facility,” Hahn said. “We are prioritizing future inspections based on the expected health benefit of the products under review and the overall importance in advancing medical care, taking into account our user-fee commitments. And we will use other tools to help prioritize future inspections.
“Of course, we recognize that potential therapies to treat patients with COVID-19 are a top priority,” Hahn added. “Our process for setting priorities will be based on the data supporting a new product, patient safety and other factors. We also want to be sure that the manufacturing capacity for therapies to treat patients with COVID-19 receives attention. We also are paying special attention to the review of generic applications for products used to treat COVID-19 patients.
“I want to thank our staff for all their incredibly hard work,” he concluded. “It has meant that the public can continue to have complete confidence in our review of medical products and in our unwavering commitment to ensuring that medical products meet our high standards for safety and effectiveness.”
Separately, Medtech trade group AdvaMed expressed its gratitude to the agency for its efforts during the pandemic.
“We appreciate the FDA’s commitment, especially during this unprecedented health care crisis, to meeting its user-fee goals, and we look forward to working with the agency to help ensure the current goals are met,” said AdvaMed spokesperson Mark Brager. “Likewise, we appreciate FDA’s effort to meet virtually with medical technology companies on product submission and other issues until in-person meetings can be safely resumed.”
This article has been updated with comments from FDA commissioner Stephen Hahn.