Actions of the Applicant: Key Points
According to the guidance, actions the applicant may take with respect to the submission include responding to a request for additional information (AI request) issued by the authority or withdrawing the submission itself – the latter could be completed by either submitting the appropriate request or leaving the request of the authority without response. The authority also mentions that both the initial 510(k) submission and subsequent requests for additional information should be accompanied by an eCopy or eSTAR. The document further describes in detail each of the actions and their impact on the review clock.
Response to an AI Request
As explained in the guidance, a response to an FDA AI request is the submission of additional information, addressing all of the deficiencies identified in that AI request, that allows the FDA to continue or complete the substantive review and reach a decision on the 510(k) submission. It is stated that once requested by the authority, the applicant should duly provide the information the FDA reasonably needs to finalize the review of the submission. When providing a response, the applicant should ensure any and all questions raised by the authority should be addressed in order for the response to be considered complete. The said action will resume the review clock.
Should the authority determine that the applicant has not addressed in full the deficiencies outlined in the request, the review cycle will be terminated until the remaining deficiencies will be duly addressed. In such a situation, the authority will notify the applicant accordingly. As mentioned in the previous article, the authority requires the applicant to provide a complete response within 180 calendar days from the date the initial request for additional information has been issued by the authority, otherwise, the application will be considered withdrawn.
The authority also mentions that in case the applicant submits unsolicited additional information (i.e., not prompted by the FDA) that constitutes a new indication for use or a new or different technology, the [applicant] will be required to submit a new 510(k) and the associated fee since the unsolicited information would essentially require FDA to restart the substantive review.
Request for Withdrawal of the 510(k) Submission
In accordance with the current legislation, the applicant has a right to withdraw the application by submitting the appropriate request to the authority. Under the general rule, such a request could be submitted at any time for any reason before the final decision is taken by the authority – once the decision is taken, such a request will not be considered by the authority.
As explained in the guidance, the aforementioned action will shut off the review clock at the moment when the appropriate request is received.
Extensions of Time to Respond to an AI Request
As prescribed by 21 CFR 807.87(m), the authority may consider a submission to be withdrawn, should the applicant fail to provide additional information requested by the authority within the respective timeframe which, under the general rule, constitutes 30 days from the date such request is issued by the authority. However, the authority intends to provide additional time for the applicants to submit a response.
According to the guidance, the period of a maximum of 180 calendar days could be used by the applicant to address the request for additional information issued by the FDA without requesting an extension in writing. At the same time, the authority explicitly states that should the applicant fail to provide a complete response on time, a notice of withdrawal will be issued by the authority.
In summary, the present FDA guidance describes different actions taken by the applicant with respect to a premarket notification submission under the 510(k) framework, and the impact these actions will have on the FDA review clock. The document pays special attention to the timeframes for providing a response to a request for additional information, and the way the extension could be provided.
How Can RegDesk Help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.