FDA 医疗器械注册分类注意事项
美国医疗器械分类目录中同一个产品系列，因预期用途和适用范围不同，分类为不同的产品类别和产品代码，直接影响FDA的申报形式 ,以血氧仪为例, 因预期用途和适用范围不同，共分为13个不同类别， DQA、DPZ、NLF、PGJ、 QLS、 OCH、 NMB、 NMD、 DQE、 MUD、 GLY、 QEM 、MMA，其中12个产品划分为2类，1个产品划分为3类，10产品需以PMN 510(K)申报， 2个产品以CDRH自由裁量权申报，1个产品以PMA形式申报，故在产品立项前，一定要分类正确，否则将严重浪费时间，成本和资源，最后还不通过。详情如下表：
| NO | Medical Specialty | Product Code | Device/Product Name | Class | Premarket Submission Required |
| 1 | ANESTHESIOLOGY | DQA | Oximeter | 2 | 510(k) |
| 2 | ANESTHESIOLOGY | DPZ | Oximeter, ear | 2 | 510(k) |
| 3 | ANESTHESIOLOGY | NLF | Oximeter, reprocessed | 2 | 510(k) |
| 4 | ANESTHESIOLOGY | PGJ | Oximeter, wellness | 2 | enforcement discretion |
| 5 | ANESTHESIOLOGY | QLS | Pulse oximeter for low-acuity settings | 2 | 510(k) |
| 6 | CARDIOVASCULAR | OCH | oximeter, infrared, sporting, aviation | 2 | enforcement discretion |
| 7 | CARDIOVASCULAR | NMB | Catheter, oximeter, fiber optic, reprocessed | 2 | 510(k) |
| 8 | CARDIOVASCULAR | NMD | Oximeter, tissue saturation, reprocessed | 2 | 510(k) |
| 9 | CARDIOVASCULAR | DQE | Catheter, oximeter, fiber-optic | 2 | 510(k) |
| 10 | GENERAL AND PLASTIC SURGERY | MUD | Oximeter, tissue saturation | 2 | 510(k) |
| 11 | HEMATOLOGY | GLY | OXIMETER TO MEASURE HEMOGLOBIN | 2 | 510(k) |
| 12 | NEUROLOGY | QEM | Cerebral oximeter | 2 | 510(k) |
| 13 | OBSTETRICS AND GYNECOLOGY | MMA | Oximeter, fetal pulse | 3 | pma |
更多美国FDA医疗器械产品注册备案常见问题及方案解决请联系深圳市思博达彭先生或登录公司网站www.bccgd.com。
