Department of Dermatology, University Hospitals Cleveland Medical Center, Case Western Reserve University, 11100 Euclid Avenue, Cleveland, Ohio, 44106.
Lasers Surg Med. 2020 Nov;52(9):837-841. doi: 10.1002/lsm.23236. Epub 2020 Mar 27.
Device innovation in dermatology is increasing. Medical devices identified as "substantially equivalent" to predicate ones by the United States Food and Drug Administration (FDA) may be exempt from premarket approval through the 510(k) pathway. The 510(k) pathway has been criticized for having less stringent clinical data requirements, and implications of dermatologic device clearance via this pathway are incompletely described. The objective of this study is to characterize dermatologic device clearance via the 510(k) pathway.
STUDY DESIGN/MATERIALS AND METHODS: We performed a retrospective review of the FDA's 510(k) database between January 1, 1996 and December 31, 2018. Dermatologic devices were included based on product code and classified by the application. Approval pathways and decision characteristics were compared among dermatologic device categories.
Of the 76,607 records screened, 4,637 met inclusion criteria. Laser/thermal devices comprised the largest category (64.2%), followed by wound (24.0%) and light-based devices (5.8%). The majority of 510(k) pathway submissions were traditional (89.2%) compared with alternative (10.8%) submission types (P = 0.003). Devices that were deemed substantially equivalent without limitations (98.5%) were the most common among all device categories. Rates of device clearance over the study period increased for all categories except laser/thermal devices.
Dermatologic devices are increasingly cleared via the FDA's 510(k) pathway through "substantial equivalence" with minimal requirements for premarket clinical data. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.
皮肤科医疗器械的创新日益增多。美国食品和药物管理局（FDA）认定与现有产品“实质等同”的医疗器械可通过 510(k)途径豁免上市前批准。510(k)途径的临床数据要求相对宽松，通过该途径获得皮肤科医疗器械许可的影响尚未得到充分描述。本研究旨在描述通过 510(k)途径获得皮肤科医疗器械许可的情况。
研究设计/材料和方法：我们对 1996 年 1 月 1 日至 2018 年 12 月 31 日 FDA 的 510(k)数据库进行了回顾性分析。根据产品代码将皮肤科医疗器械纳入研究，并根据应用对其进行分类。比较了皮肤科医疗器械各分类的批准途径和决策特征。
在所筛选的 76607 条记录中，有 4637 条符合纳入标准。激光/热能设备占比最大（64.2%），其次是伤口（24.0%）和光基设备（5.8%）。与替代（10.8%）提交类型相比，传统（89.2%）提交类型是 510(k)途径提交的主要类型（P = 0.003）。所有设备分类中，最常见的是没有限制的“实质等同”设备（98.5%）。除激光/热能设备外，所有类别的设备批准率在研究期间均有所增加。
皮肤科医疗器械通过“实质等同”和最少的上市前临床数据要求，越来越多地通过 FDA 的 510(k)途径获得许可。激光外科学杂志。2020 年 Wiley 期刊出版公司。
