The International Medical Device Regulators Forum is inviting stakeholder comment on a draft proposal for using real-world data from patient registries in regulatory decision making.
Stakeholders should compare the proposal to their current processes and consider closing any evidence gaps, IMDRF said. The assessment elements in the proposal are expected to promote consistency, predictability and transparency in maximizing the use of real-world data in evaluating device safety and effectiveness.
The draft proposes recommendations on the following regulatory uses: primary approval, expanded indications, post-market studies, post-market surveillance, objective performance criteria/performance goals and device tracking and field safety corrections.
The proposed assessment elements are intended to promote convergence of regulatory approaches, enhance technical capabilities of regulators and stakeholders and generate faster evidence.