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

Expert Rev Med Devices. 2026 Oct 28. doi: 10.1080/17434440.2026.2750118. Online ahead of print.

ABSTRACT

BACKGROUND: High-risk chronic pain devices undergo postapproval modifications via supplement pathways with varying evidentiary requirements, but their extent has not been systematically characterized.

METHODS: 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).

RESULTS: Seventeen original PMAs were identified: 8 spinal cord stimulators (47.1%), 7 shock-wave generators (41.2%); 10 (58.8%) were implantable. Fourteen devices (82.4%) generated 1,343 supplements over a median follow-up of 4.5 years (IQR, 2.8-20.7). Supplement activity was highly concentrated: 3 spinal cord stimulators accounted for 83.2% of all modifications. Among the three highest-contributing PMAs, median inter-supplement intervals were 11, 12, and 22.5 days. Most used 30-Day Notice (56.3%) or Real-Time pathways (17.3%). Process or manufacturing changes accounted for 61.4% of supplements, followed by design changes (24.6%). From 2005-2025, 93 recalls occurred, 91 (97.8%) involving spinal cord stimulators; 87.1% were Class II recalls.

CONCLUSIONS: Extensive postmarket modification of high-risk chronic pain devices was concentrated in a small number of implantable spinal cord stimulators and occurred mainly via pathways not requiring new clinical data. These findings underscore the importance of interpreting marketed devices in the context of their complete postapproval histories.

PMID:42948973 | DOI:10.1080/17434440.2026.2750118