PMI submission
Pronunciation: P-M-I submission
Also written as: PMI — Premarket Investigation
A premarket investigation submission to regulatory authorities for approval to conduct clinical studies of cardiac devices before commercial approval.
Full Definition
A PMI (Premarket Investigation) submission is a regulatory filing required before initiating clinical studies of investigational cardiac devices in many jurisdictions. This comprehensive document package includes detailed device specifications, preclinical testing data, clinical protocol, risk-benefit analysis, and manufacturing information. The PMI process allows regulatory bodies to evaluate the safety and scientific validity of proposed clinical trials before human subjects are exposed to investigational devices. Unlike the FDA's IDE (Investigational Device Exemption) pathway, PMI submissions are typically used in international markets and may have different requirements for clinical data, quality systems, and post-market surveillance. Successful PMI approval is often a prerequisite for conducting pivotal trials that support eventual commercial approval.
Usage
Usage note: Always spell out 'Premarket Investigation' on first use, followed by '(PMI)'. Distinguish from FDA's IDE pathway in international contexts.
In Context
- "The company's PMI submission for the novel leadless pacemaker was approved by Health Canada after a six-month review." — Regulatory affairs report
- "Key components of the PMI submission included biocompatibility data and electromagnetic compatibility testing results." — Clinical development plan