2025-05-24
我国医械审批体系:宽松而不放任Loose but not laissez faire
根据FDA的要求，新药上市须经过临床试验以证明安全性和有效性。反观医疗器械审批，大多数只需表明与已有产品相似。真正属于创新的医疗器械则必须接受更加严格的临床检测。
这份报告出台之际，正值FDA应对来自医械厂家如潮水般的质疑。业界表示，FDA审批医疗器械的流程过于缓慢和官僚，无形中推高了医疗器械生产商的成本，迫使部分生产商退出这一领域，不久前，强生公司退出药物洗脱支架市场就是一大例证。过去一年来，医疗器械生产商向美国国会提交了意见，国会议员就医疗器械的审批程序向FDA提出质问。
然而，IOM小组成员（大多为医生和研究人员）此次一边倒地与FDA站在了一起。多年来，公众安全倡导者——FDA坚持认为，用于治疗和检测的医疗器械须经过实际医疗测试。
FDA之所以寻求专家小组的建议，是因为它打算修订美国医疗器械审批的相关体系。510(k)审批体系由美国国会于1976年创建，如果生产厂家新开发的医疗器械与已上市产品相似，该审批体系将给予快速审批资格。初，该审批路径计划作为临时处置办法，面向那些上市多年的老产品。而现在已成为医用植入物的一个标准审批工具。
According to FDA requirements, new drugs must undergo clinical trials to demonstrate safety and efficacy before being marketed. On the other hand, in the approval of medical devices, most only need to indicate that they are similar to existing products. Truly innovative medical devices must undergo stricter clinical testing.
This report is being released at a time when the FDA is responding to a flood of questions from medical device manufacturers. The industry has expressed that the FDA's approval process for medical devices is too slow and bureaucratic, which invisibly increases the costs of medical device manufacturers and forces some manufacturers to withdraw from this field. Recently, Johnson&Johnson's withdrawal from the drug-eluting stent market is a major example. Over the past year, medical device manufacturers have submitted their opinions to the US Congress, and members of Congress have questioned the FDA about the approval process for medical devices.
However, members of the IOM team (mostly doctors and researchers) sided with the FDA this time. For many years, public safety advocate FDA has insisted that medical devices used for treatment and testing must undergo actual medical testing.
The FDA is seeking advice from a panel of experts because it intends to revise the relevant system for medical device approval in the United States. The 510 (k) approval system was created by the US Congress in 1976. If a manufacturer develops a medical device that is similar to an already marketed product, the approval system will grant expedited approval eligibility. At the beginning, this approval path plan was intended as a temporary disposal measure for old products that have been on the market for many years. And now it has become a standard approval tool for medical implants.
