The article provides an overview of the performance goals related to the applications under the premarket approval framework.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the premarket approval applications (PMAs) in the context of the review clock and goals. In particular, the document describes the way different actions performed by the parties involved will impact the review clock.
It is also important to mention that FDA guidance documents are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. Moreover, an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.
The scope of the guidance covers, inter alia, the performance goals set forth under MDUFA V. According to the document, these goals include:
- For original PMA and panel-track supplement submissions received in FY 2023 through FY 2024, the average shared outcome Total Time to Decision goal for FDA and industry is 290 calendar days; and
- For original PMA and panel-track supplement submissions received in FY 2025 through FY 2027, the average shared outcome Total Time to Decision goal for FDA and industry is 285 calendar days.
The document further describes the main steps of the application process and outlines the measures to be taken to ensure the said performance goals are achieved.
Under the general rule, an applicant is obliged to comply with the electronic submission requirements, and also pay the appropriate fee. Unless these steps are completed, the authority will not commence its review. The authority refers to the separate guidance documents dedicated to electronic submissions for further reference on the said matters.
Acceptance and Filing Review, Supplements
As the very first stage of the application review process, the authority will perform an administrative review in order to ensure all the key elements of the submission are in place. Should any missing information or documents be identified, the authority will inform the applicant in writing within 15 calendar days from the date the appropriate application has been received by the authority. At the same time, the authority additionally emphasizes that more deficiencies could be identified in the course of subsequent application review, so the aforementioned communication referring to the preliminary review should not prevent the authority from notifying the applicant of other deficiencies.
In case any deficiencies are identified, the application review will be placed on hold, and the review clock will not start. Once the missing documentation is duly provided by the applicant, the authority will commence the review and the date when all the necessary documents were received by the FDA will be considered the new application date.
In order to ensure that the medical device in question complies with any and all applicable regulatory requirements in terms of safety, quality, and effectiveness, the authority will conduct a substantive review. In the course of such a review, the authority may issue a Substantive Interaction communication – for instance, to notify the authority about the major deficiency identified. However, a Substantive Interaction communication will also take place in case of an approval or approvable letter issued by the authority. According to the guidance, after a Substantive Interaction, FDA intends to work with the applicant via Interactive Review to reach a MDUFA decision.
MDUFA V Goals
The document further describes in detail the aspects related to MDUFA V goals. As explained by the FDA, they are calculated in terms of FDA Days, standing for those calendar days when a submission is considered to be under review at the Agency for submission that has been filed; FDA Days begin on the date of receipt of the submission or the amendment to the submission that enables the submission to be filed.
Another important concept described in the guidance is a Total Time to Decision which is the time spent by FDA reviewing the application as well as the time spent by the applicant responding to questions from FDA. In the context of the guidance, the Total Time to Decision is to be calculated starting from the date a complete submission has been received by the authority. When evaluating the progress, the authority will calculate the average Total Time to Decision for the application reviewed. In order for the goal to be achieved, 95% of the applications should be reviewed within the timeframe set forth by the authority as its performance target.
Missed MDUFA Decision Communication
The authority further explains that for all PMA original and panel-track supplements that do not reach a MDUFA decision by 20 calendar days after the applicable FDA Day goal, FDA will provide a missed MDUFA decision communication, which is written feedback to the applicant to be discussed in a meeting or teleconference, including the major outstanding review topic areas or other reasons that are preventing FDA from reaching a decision as well as an estimated date of completion.
In summary, the present FDA guidance provides additional clarifications with respect to the performance goals set forth under MDUFA V. The authority explains how exactly they should be calculated based on the actions of all the parties involved in the respective regulatory processes.
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