Nonconcurrent Control Use in FDA Approval of High-Risk Medical Devices.

ABSTRACT:

Importance

The US Food and Drug Administration (FDA) may consider historical controls, objective performance criteria, or performance goals as alternatives to concurrent control groups in clinical studies evaluating safety and/or effectiveness of high-risk medical devices. However, nonconcurrent control use has limitations.

Objective

To examine frequency, justification, and clinically relevant details for use of nonconcurrent controls in pivotal studies supporting FDA approval of high-risk medical devices.

Design, setting, and participants

Cross-sectional study from 2019 through 2023 of original high-risk therapeutic medical device approvals in the US.

Main outcomes and measures

Frequency, justification, and clinically relevant details for use of historical con

SUBMITTER: Mooghali M 

PROVIDER: S-EPMC12015671 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature