FDA-cleared home sleep apnea testing devices
Year: 2024
Type: article
Abstract: The demand for home sleep apnea testing (HSAT) devices is escalating, particularly in the context of the coronavirus 2019 (COVID-19) pandemic. The absence of standardized development and verification procedures poses a significant challenge. This study meticulously analyzed the approval process characteristics of HSAT devices by the U.S. Food and Drug Administration (FDA) from September 1, 2003, to September 1, 2023, with a primary focus on ensuring safety and clinical effectiveness. We examined 58 reports out of 1046 that underwent FDA clearance via the 510(k) and de novo pathways. A substantial surge in certifications after the 2022 pandemic was observed. Type-3 devices dominated, signifying a growing trend for both home and clinical use. Key measurement items included respiration and sleep analysis, with the apnea-hypopnea index (AHI) and sleep stage emerging as pivotal indicators. The majority of FDA-cleared HSAT devices adhered to electrical safety and biocompatibility standards. Critical considerations encompass performance and function testing, usability, and cybersecurity. This study emphasized the nearly indispensable role of clinical trials in ensuring the clinical effectiveness of HSAT devices. Future studies should propose guidances that specify stringent requirements, robust clinical trial designs, and comprehensive performance criteria to guarantee the minimum safety and clinical effectiveness of HSATs.
Source: npj Digital Medicine
Authors: Ji Hyeun Park, Changwon Wang, Hangsik Shin
Institutions: Asan Medical Center, University of Ulsan
Language: English
Subfield: Physiology (medical)
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,790
Awards: G2581356091, G2854254613, G8513767859
OpenAlex ID: W4396852687