FDA updates modular review program guidance; adds humanitarian device exemptions

The US Food and Drug Administration (FDA) has updated a guidance on its expectations for sponsors who want to use its modular review program. The program was previously open to premarket approval applications (PMA), but the updated final guidance also addresses sponsors of humanitarian device exemptions (HDE).

FDA initially issued guidance in 2003 on its modular review program for PMAs, but over the past two decades, the agency has updated its policies for the program, necessitating an update to the guidance. On 13 January, the agency published an updated final guidance that includes processes for modular HDE submissions, taking into consideration new electronic submission capabilities at the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), and clarifying the steps sponsors can take during early-stage modular review and after converting to a traditional PMA or HDE.

Traditionally, PMA and HDE sponsors submit all their data simultaneously, which triggers FDA reviewers to evaluate their products. However, the agency allows some products in their early development stages to submit their data sooner using its modular review process to help speed up their evaluation.

"The modular review approach is intended to provide a mechanism by which applicants may submit non-clinical data and manufacturing information for review while still collecting, compiling, and analyzing the clinical data using the final device design," said FDA. "Therefore, a modular PMA or HDE is a compilation of sections or 'modules' submitted at different times that together become a complete application.

"The goal of this approach is to increase the efficiency of the review process by allowing applicants to submit discrete modules of the application to FDA for review soon after completing the non-clinical testing and analysis," the agency added. "Additionally, the modular approach allows the applicant to potentially resolve any deficiencies noted by FDA earlier in the review process than would occur with a traditional PMA or HDE application."

FDA noted that the modular review process is more suitable for PMAs and HDEs in the early stages of their clinical development and is not appropriate for products that are nearly complete for submission or when a product may undergo changes before it is submitted for review. The agency also noted that the program is not for PMA and HDE supplements.

The final guidance includes a decision flow chart that sponsors can use if they want to use the modular review program. The first step is to email FDA to state their intent to use the program and propose an informal shell that lists the modules they want to use. If the sponsor's request is accepted and a shell is agreed on, sponsors are asked to use the CDRH Customer Collaboration Portal (CDRH Portal) or the FDA Electronic Submission Gateway for products to be reviewed by CBER. Alternately, sponsors who want to submit to CBER can email the center directly.

FDA also includes an appendix with sample shells; sponsors are urged to use them whenever possible, according to the agency.

"Ideally, there should be no more than 3-4 modules," the FDA noted. "However, we understand that there may be instances when the recommended model is not suitable and should be modified. The review staff will work with you to establish a shell that is acceptable to both parties during the shell review."

Updated final guidance

FDA updates modular review program guidance; adds humanitarian device exemptions

Related topics

Recommended content

Welcome to the new RAPS Digital Experience