The U.S. Food and Drug Administration (FDA) released final guidance "Premarket Approval Application and Humanitarian Device Exemption Modular Review" to enhance the efficiency and flexibility of the Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) processes through modular reviews. This method enables applicants to submit discrete sections or "modules" of their application for evaluation, rather than submitting the entire application at once.
Module: A discrete section of the application, such as non-clinical or manufacturing data, submitted independently for review.
Traditionally, PMA and HDE applicants were required to submit all necessary data simultaneously, causing delays in the review process.
The modular review approach, codified under the Medical Device User Fee and Modernization Act (MDUFMA), enables applicants to submit sections incrementally. This change aims to:
Expedite the review process.
Address potential deficiencies earlier in the process.
Provide flexibility for applicants managing long development timelines.
The FDA's modular review approach facilitates submitting PMA and HDE applications in a segmented format. This method is particularly advantageous for products in early clinical development stages, as it allows the FDA to review non-clinical and manufacturing data. At the same time, applicants continue to collect clinical data using the finalized device design.
This modular review program applies only to original PMA and HDE applications, excluding supplements. The FDA encourages this approach for devices in early clinical stages but advises against it when device designs are unstable or nearing final submission. For modular PMAs, the user fee must be paid upon the submission of the first module. HDEs, however, are exempt from user fees. Importantly, modular PMAs have distinct refund policies compared to traditional applications.
The Submission Process involves the following steps
1. Contact Review Group: Applicants must initially engage with the FDA's review division to discuss their intent and establish the shell for their modular application.
2. PMA or HDE Shell: The shell serves as a roadmap for the submission, outlining the content and schedule for each module. The FDA emphasizes the need for careful planning to avoid delays or re-evaluation due to changes in device design.
3. Modular Submission: Each module must include:
A cover letter
Table of contents.
Executive summary.
Relevant device descriptions and test data.
4. Review Timeline: The FDA aims to review each module within 90 days. Interactive communication is encouraged to address minor issues during the review process.
5. Final Module Submission: The final module consolidates all previous modules, including responses to any outstanding deficiencies. Upon receipt, the FDA converts the modular application into an original PMA or HDE for comprehensive review.
For more details, refer to the complete guidance document: FDA Modular Review Guidance.
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