The FDA already subjects most medical devices to much less stringent approval requirements than drugs and biologics, and attempts to speed up rollout during the COVID crisis have been problematic. Agency decisions, including to allow antibody test marketing without emergency use authorization or review, and the back-and-forth guidance on laboratory-developed tests, have met harsh criticism and unreliable results. Though the long-term results of these decisions are unclear, the FDA’s credibility, reliability, and commitment to safety are threatened by even further lessening medical device regulatory oversight during the coronavirus pandemic. The relaxed and fix-it-later approach to many of the FDA’s public health emergency decisions regarding medical devices reflect the ongoing criticisms of medical device regulation in general, specifically the 510(k) process and laboratory developed test regulation, offering a point of reflection towards reform. Adaptive legislation and a risk-based and evidentiary approach to premarket and postmarket review can begin to address these issues both generally and in an emergency context.

中文翻译：

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放松医疗器械监管监督：FDA 和 COVID-19 大流行中的测试

与药物和生物制品相比，FDA 已经对大多数医疗器械的审批要求严格得多，并且在 COVID 危机期间加快推广的尝试一直存在问题。机构的决定，包括允许未经紧急使用授权或审查的抗体测试营销，以及对实验室开发测试的反复指导，都遭到了严厉的批评和不可靠的结果。尽管这些决定的长期结果尚不清楚，但 FDA 的信誉、可靠性和对安全的承诺受到了在冠状病毒大流行期间进一步减少医疗器械监管监督的威胁。FDA 对许多有关医疗器械的公共卫生紧急决定采取的宽松和稍后修复的方法反映了对医疗器械监管的持续批评，特别是 510(k) 流程和实验室制定的测试法规，为改革提供了一个反思点。适应性立法以及基于风险和证据的上市前和上市后审查方法可以开始在一般情况下和在紧急情况下解决这些问题。