The FDA revised its guidance document to give medical device sponsors additional time to respond to requests for more information about applications that were put on hold due to the COVID-19 pandemic. Specifically, sponsors now have 180 additional days beyond original deadlines to submit responses to FDA requests before applications are withdrawn. This applies to pre-market approval applications, humanitarian device exemptions, de novo requests, and 510(k) applications. The FDA acknowledged it may not be able to meet usual review timelines due to priorities and resource constraints from the ongoing pandemic.

1. FDA Extends the Timeline to Respond to
Additional Information Requests
By: Nikita Angane
The FDA revised its guidance document ‘Effects of the COVID-19 Public Health
Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and
Answers’ which was originally released in June, to give device sponsors additional time in
responding to FDA’s requests for additional information for device applications that are on hold.
At the onset of the pandemic, FDA realized that device makers were faced with
unprecedented challenges related to supply chain issues, human resources, etc., while on the
other hand, the FDA saw a surge in EUA activities which required shifting of staff resources at
the FDA. During this time, the FDA released a guidance document to extend the timeline for
responding to the FDA’s requests for submissions/applications that were put on hold. The
originally released guidance document provided a sigh of relief to device sponsors by allowing
an additional 90 day period beyond the response date initially assigned. 1
Under the revision of the same guidance document, the FDA provides an additional 180
days for submission of responses to the FDA’s requests before they are withdrawn. For
premarket approval (PMA) applications and humanitariandevice 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.1
This policy applies to the submission types listed below, which are placed on hold
pending additional information or complete response to a major deficiency for PMA or HDE.
These submission types do not require the submission of an extension request by the sponsor:1
 Pre-market application
 Humanitarian Device Exemption
 De Novo applications
 510(k)
FDA also mentioned in the guidance document that due to the pandemic and emergency
authorization services taking a priority in its operations, it is not able to keep up with the current
level of performance associated with the timelines and plans on communicating any delays
directly with the sponsor.1 EMMA International is here to help you with all your regulatory
needs, call us at +1 248-987-4497 or email us at info@emmainternational.com.
1 FDA (Dec 2020) Effects ofthe COVID-19 Public Health Emergencyon Formal Meetings andUser Fee Applications for Medical
Devices — Questions andAnswers (Revised) retrievedon12/27/2020 from https://www.fda.gov/media/139359/download