The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has written to the medical device industry to outline its response to the COVID-19 public health emergency in its day-to-day operations with industry.
The letter from the agency details that it aims to “prioritise work that advances the nation’s response during this national emergency”. Among the steps it has taken are converting in-person meetings to teleconferences, and changes to its processing of incoming documents, as well as extending response due dates for marketing applications that are currently on hold.
Meetings with industry scheduled up to 30 April are being switched to a teleconference to be held at the same date and time. The agency says it will continue to assess whether any in-person meetings arranged beyond that date should be converted to teleconferences, and promises to provide periodic updates.
The CDRH also indicates that although the Document Control Center continues to receive and process incoming documents it is “generally unable to accept incoming submissions via email”, and it is looking into other electronic options.
Marketing applications that were on hold as of 16 March with a response due date on or before 30 April have had their response due dates extended by 60 days. The extension relates to Premarket Notifications (510[k]s), Premarket Approval (PMA) applications (original and supplements), Humanitarian Device Exemption (HDE) applications (original and supplements) and De Novo classification requests. The agency says this will occur automatically, without the need to submit a request. In cases of additional submission types where a response or report is due (for example, Post Approval or 522 Study reports, Investigational Device Exemption annual reports, PMA reports), the CDRH encourages that the response or report be submitted when possible.
The Postmarket and Compliance Activities at the CDRH will continue to process and work on mission critical post-market and compliance activities. “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,” states the organisation.
Share your stories
If you have been affected or have any information, we’d like to hear from you. You can get in touch by emailing the editor at [email protected] and one of our journalists may contact you to discuss this further.
