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PubMed

Post-approval modification of high-risk chronic pain devices approved through the FDA premarket approval pathway, 1981-2023.

PMID: 42948973 ·

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JournalExpert review of medical devices
Year
PMID42948973

Abstract

High-risk chronic pain devices undergo postapproval modifications via supplement pathways with varying evidentiary requirements, but their extent has not been systematically characterized. Cross-sectional analysis of PMA-approved chronic pain devices (1981-2023) using supplement data from openFDA and recall data from the FDA Medical Device Recalls database (2005-2025). Seventeen original PMAs were identified: 8 spinal cord stimulators (47.1%), 7 shock-wave generators (41.2%); 10 (58.8%) were imp

Official Source

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