US FDA Advisory Panel Members' Assessment of Premarket Approval Process and Suggestions for Improvement.

ABSTRACT:

Importance

The manufacturing and marketing of medical devices is regulated by the US Food and Drug Administration (FDA), and the FDA premarket approval (PMA) process evaluates the safety and effectiveness of medical devices. The PMA process includes a detailed scientific, regulatory and quality system review and is critical to ensure that novel devices are safe, effective, and meet the needs of patients.

Objective

To survey current voting members serving on panels of the FDA's Medical Devices Advisory Committee to better characterize panel decision-making and identify steps for improvement.

Design, setting, and participants

This qualitative survey study included 36 questions that were mailed to FDA device panelists regarding their opinions on the influence of sources

SUBMITTER: Alam M 

PROVIDER: S-EPMC11581643 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature