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PMN510(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，Zui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 |
