In the intricate landscape of medical device development and approval, navigating regulatory pathways can be daunting. Among the pivotal steps in this journey lies the FDA Pre-Submission process. This process serves as a crucial bridge between medical device developers and regulatory authority, facilitating effective communication, feedback, and ultimately, smoother pathways towards product clearance or approval. Understanding the significance of FDA Pre-Submission is critical for medical device companies striving for compliance, efficiency, and successful market entry.
Last week, FDA issued an updated draft guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” as part of the Medical Device User Fee Amendments of 2022 (MDUFA V) and the FDA’s refined performance goals related to Pre-Submissions or “Pre-Subs.”
The updated guidance is intended to provide an overview of the various mechanisms that are available to submitters through which they can request interactions with the FDA related to medical device submissions. These interactions can include written feedback and/or a meeting related to potential or submitted medical Premarket Notification (510(k) submissions), Investigational Device Exemption (IDE) applications, De Novo Requests and more.
With commitments to refine the Q-Submission (Q-Sub) Program with changes related to the schedule of Pre-Sub meetings and a new performance goal on the timing of FDA feedback for Pre-Subs, FDA’s latest guidance also assists applicants and review staff in identifying the circumstances in which an applicant’s question is most appropriate for informal communication instead of a Pre-Sub.
As background, the FDA Pre-Submission includes a formal written request from a submitter for feedback from FDA that is provided in the form of a formal written response or if the submitter elects, formal written feedback followed by a meeting. The Pre-Sub process provides a platform for medical device developers to seek clarity on regulatory requirements specific to their product. This proactive engagement enables companies to align their development strategies with FDA expectations from the outset. By obtaining insights into regulatory standards, testing methodologies, and documentation requirements, developers can streamline their efforts, mitigate risks, improve the quality of submissions, shorten total review times, and allocate resources effectively. Moreover, understanding regulatory expectations early on can prevent costly delays and setbacks during the later stages of product development. In FDA’s latest draft guidance, the Agency outlines the circumstances in which a Pre-Sub is most appropriate, including to help guide product development (e.g. appropriate regulatory classification), to obtain feedback on the development of Predetermined Change Control Plans prior to inclusion in a premarket submission, and to generally help prepare for submission.
Navigating the regulatory landscape without prior feedback can expose medical device developers to uncertainties and risks. The FDA Pre-Submission process serves as a risk mitigation tool by enabling developers to identify and address potential regulatory concerns early in the development cycle. By engaging with the FDA, developers can assess the regulatory impact of design changes, clinical study protocols, and data interpretation strategies. This proactive approach minimizes the likelihood of surprises during the formal submission process, optimizes pathways to regulatory clearance or approval to allow developers to gain a competitive edge in the marketplace and increases the probability of regulatory success.
For more information on FDA’s draft guidance, the Q-Sub/Pre-Submission process, and/or assistance with medical device, FDA 510(k) premarket notifications, please contact us at info@garg-law.com.
