Posted 22 June 2020 | By
The US Food and Drug Administration (FDA) on Monday issued an immediately effective questions and answers guidance explaining the impact of the coronavirus disease (COVID-19) public health emergency on formal meetings and applications for medical devices.
FDA released a similar guidance pertaining to formal meetings and applications for drugs and biologics amid the pandemic in late May. (RELATED: FDA explains impact of COVID-19 on applications, formal meetings, Regulatory Focus 27 May 2020).
Specifically, the six-page guidance provides answers to eight questions on FDA’s handling of meetings and Medical Device User Fee Amendments (MDUFA) performance goals and timelines.
“Until further notice, all requests for in-person meetings will be handled as requests for teleconferences, and all [Center for Devices and Radiological Health] CDRH meetings previously scheduled as in-person meetings have been converted to teleconferences to be held as the same date and time,” FDA says, noting that the Center for Biologics Evaluation and Research (CBER) may use either teleconference or videoconference technologies for its meetings.
FDA also says it is continuing to accept new Q-submission requests, all of which the agency says will be handled via teleconference or, at the request of the sponsor, by written response only.
As with drugs and biologics, FDA says it believes it can conduct advisory committee meetings for medical devices virtually, and that it will discuss the possibility with sponsors. FDA adds that advisory committee meetings covering regulatory issues may be held virtually as well.
FDA also concedes that it may miss some of its MDUFA performance goals, including those for biologics license application (BLA) devices, as a result of the pandemic, citing the increased workload related to emergency use authorizations (EUAs) and developing policies related to COVID-19.
In the case of a missed MDUFA goal, FDA says it will follow the missed MDUFA decision procedures laid out in its guidances for various submission types’ review clock and goals. However, as with its goals for drugs and biosimilars, the agency says the “MDUFA commitment letter does not contemplate FDA extending or changing user fee goal dates,” except in specific cases such as the submission of an unsolicited major amendment that would trigger a clock extension.
Additionally, FDA explains that it will give device sponsors an additional 90 days to respond to major deficiency letters for premarket approval (PMA) and humanitarian device exemption (HDE) applications and to additional information letters for 510(k)s and de novo requests for submission and applications on hold as of 16 March 2020.
“FDA does not intend to consider a submission or application to be withdrawn for an additional 90 days beyond the relevant response date,” the agency writes, adding that the additional 90 days applies regardless of whether an applicant has submitted an extension request.
FDA released a similar guidance pertaining to formal meetings and applications for drugs and biologics amid the pandemic in late May. (RELATED: FDA explains impact of COVID-19 on applications, formal meetings, Regulatory Focus 27 May 2020).
Specifically, the six-page guidance provides answers to eight questions on FDA’s handling of meetings and Medical Device User Fee Amendments (MDUFA) performance goals and timelines.
“Until further notice, all requests for in-person meetings will be handled as requests for teleconferences, and all [Center for Devices and Radiological Health] CDRH meetings previously scheduled as in-person meetings have been converted to teleconferences to be held as the same date and time,” FDA says, noting that the Center for Biologics Evaluation and Research (CBER) may use either teleconference or videoconference technologies for its meetings.
FDA also says it is continuing to accept new Q-submission requests, all of which the agency says will be handled via teleconference or, at the request of the sponsor, by written response only.
As with drugs and biologics, FDA says it believes it can conduct advisory committee meetings for medical devices virtually, and that it will discuss the possibility with sponsors. FDA adds that advisory committee meetings covering regulatory issues may be held virtually as well.
FDA also concedes that it may miss some of its MDUFA performance goals, including those for biologics license application (BLA) devices, as a result of the pandemic, citing the increased workload related to emergency use authorizations (EUAs) and developing policies related to COVID-19.
In the case of a missed MDUFA goal, FDA says it will follow the missed MDUFA decision procedures laid out in its guidances for various submission types’ review clock and goals. However, as with its goals for drugs and biosimilars, the agency says the “MDUFA commitment letter does not contemplate FDA extending or changing user fee goal dates,” except in specific cases such as the submission of an unsolicited major amendment that would trigger a clock extension.
Additionally, FDA explains that it will give device sponsors an additional 90 days to respond to major deficiency letters for premarket approval (PMA) and humanitarian device exemption (HDE) applications and to additional information letters for 510(k)s and de novo requests for submission and applications on hold as of 16 March 2020.
“FDA does not intend to consider a submission or application to be withdrawn for an additional 90 days beyond the relevant response date,” the agency writes, adding that the additional 90 days applies regardless of whether an applicant has submitted an extension request.
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