Devices

Guide on Device PMA/HDE Modular Reviews

FDA has posted a guidance entitled “Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) Modular Review.” The document provides information regarding the modular review program and outlines the procedures for submitting or reviewing a modular PMA or HDE.

Unlike a traditional PMA or HDE when an applicant submits all data at the same time, the modular 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, the guidance says. The goal of this approach is to increase the efficiency of the review process by allowing FDA to review more promptly sections that were completed after non-clinical testing and analysis. “Additionally, the modular approach allows the applicant to potentially resolve any deficiencies noted by FDA earlier in the review process,” it says.

The modular approach is recommended by FDA for products that are in early stages of the clinical study. “This modular review approach is not appropriate when the applicant is very close to submitting an original PMA or HDE or when the device design is in a state of flux or likely to change,” it says.

Additionally, the guidance provides a “sample shell” to use that outline each module in the submission and its contents. A recommended shell proposal should address all elements FDA’s regulations require in a submission, as well as the projected submission date of each module, FDA says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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