Regulatory
Modular PMA
In one line
PMA submission strategy where a manufacturer submits portions of the PMA (modules) sequentially as they become ready, rather than as a single complete application.
Definition
Modular PMA review permits review of agreed portions of an original PMA as they become available under a shell describing module content and timing. The final module completes the application and initiates the applicable complete-application review process. Earlier scientific review is not deferred until all modules are accepted, and the module structure is not a mandatory three-module sequence. Discuss suitability and the shell with FDA; a formal Pre-Submission meeting is not universally required.
Why it matters
Modular PMA review permits review of agreed portions of an original PMA as they become available under a shell describing module content and timing. The final module completes the application and initiates the applicable complete-application review process. Earlier scientific review is not deferred until all modules are accepted, and the module structure is not a mandatory three-module sequence. Discuss suitability and the shell with FDA; a formal Pre-Submission meeting is not universally required.
Common pitfalls
- •Skipping the pre-submission negotiation of module scope, modules submitted without FDA agreement may be rejected or restarted.
- •Treating modular review as a way to defer hard decisions, FDA may still raise major deficiencies that affect later modules.
- •Plan resources for the agreed number of modules and interactive review cycles rather than assuming exactly three rounds.
Sources
- PMA Modular Review Guidance · FDA
- European Commission - Medical Devices · European Commission
- IMDRF Documents · IMDRF
- FDA January 2025 modular PMA and HDE guidance · FDA