Posted 23 December 2020 | By
The US Food and Drug Administration (FDA) on Tuesday revised its guidance on meetings and user fee applications for medical devices during the COVID-19 pandemic to give device sponsors more time to submit responses to the agency for applications or submissions that are on hold.
The guidance, initially released in June, was also updated to note that it can hold advisory committee meetings virtually, something the agency was still reviewing the feasibility of at the time the guidance was issued. (RELATED: FDA explains COVID-19 impact on MDUFA goals, meetings, Regulatory Focus 22 June 2020).
In recognition of the challenges device makers face during the COVID-19 pandemic, FDA extended the deadline for companies to submit responses to the agency for marketing submissions and applications on hold before they are considered withdrawn. For premarket approval (PMA) applications and humanitarian device exemption (HDE) applications, FDA typically allows 360 days for applicants to submit a complete response to a major deficiency letter and 180 days for responses to additional information letters for 510(k)s and de novo requests.
While the agency initially offered device makers an additional 90 days beyond the relevant response date, the revised guidance bumps the extension up to 180 days.
FDA notes that the policy applies to the aforementioned application and submission types regardless of whether an extension request has been submitted and clarifies that such a request is not required.
FDA
The guidance, initially released in June, was also updated to note that it can hold advisory committee meetings virtually, something the agency was still reviewing the feasibility of at the time the guidance was issued. (RELATED: FDA explains COVID-19 impact on MDUFA goals, meetings, Regulatory Focus 22 June 2020).
In recognition of the challenges device makers face during the COVID-19 pandemic, FDA extended the deadline for companies to submit responses to the agency for marketing submissions and applications on hold before they are considered withdrawn. For premarket approval (PMA) applications and humanitarian device exemption (HDE) applications, FDA typically allows 360 days for applicants to submit a complete response to a major deficiency letter and 180 days for responses to additional information letters for 510(k)s and de novo requests.
While the agency initially offered device makers an additional 90 days beyond the relevant response date, the revised guidance bumps the extension up to 180 days.
FDA notes that the policy applies to the aforementioned application and submission types regardless of whether an extension request has been submitted and clarifies that such a request is not required.
FDA
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December 24, 2020 at 03:58AM
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FDA extends timeline for device submissions on hold during pandemic - Regulatory Focus
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