美利体育登录入口官网:AAMI TIR48-2015(2021)
质量管理体系 (QMS) 关于遵守 FDA 组合产品最终规则的指导
Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products
- 标准号
- AAMI TIR48-2015(2021)
- 发布
- 2021年
- 总页数
- 28页
- 发布单位
- 美国医疗器械促进协会
- 本体
- 质量体系
- 适用范围
- This Technical Information Report (TIR) provides information about how to effectively implement the FDA’s regulation on current good manufacturing practices (CGMP) for combination products. Combination products are therapeutic or diagnostic medical products that combine drugs, devices, and/or biological products with one another. The FDA regulation became effective 22 July 2013 (21 CFR Part 4). Final guidance on CGMPs for combination products was issued in January 2017, and a list of alternative or streamlined mechanisms for compliance with CGMPs for combination products was later issued in September 2022 . This TIR, where appropriate, also considers best practices, guidelines, and standards used in both the United States and other regions. The overall goal of the TIR is to aid informed, risk-based decisions in establishing CGMP operating systems that support development, manufacture, premarket regulatory evaluation, and commercialization of combination products. It should be noted that, while the information contained in the TIR has been carefully considered, it is up to the individual manufacturer to ensure compliance with all regulatory requirements that apply to its products.
| 术语 | 描述 |
|---|---|
| 组合产品 Combination Product | 必须包含两种或多种不同类型医疗产品的产品（例如药物和器械，而不是药物和药物） |
| 共同包装组合产品 Co-packaged Combination Product | 由药物、器械和/或生物制品相互包装在一起组成的组合产品 |
| 单一实体组合产品 Single-entity Combination Product | 由两种或多种药物、器械和/或生物制品在物理、化学或其他方式上结合或混合以产生单一实体的组合产品 |
| 交叉标签组合产品 Cross-labeled Combination Product | 需要一起使用以实现预期用途、适应症或治疗效果的分别包装的药物、器械和生物制品 |
| 简化方法 Streamlined Approach | FDA为组合产品CGMP合规性制定的简化监管框架 |
美利体育登录入口官网: AAMI TIR48-2015(2021) 中提到的仪器美利体育官网首页网址
| 药物洗脱支架 | 涂有或浸渍药物的医疗器械，用于血管治疗 |