About FDA
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515 Project Status
- Step 1: FDA collects existing information
- Step 2: FDA assesses the risks and benefits
- Step 3: FDA issues proposed rule, which proposes classification of device type into Class I, II, or III
- Step 4: FDA receives and reviews comments provided
- Step 5: FDA issues final rule, which finalizes classification of device type into Class I, II, or III
| Regulation Name | CFR | Product Codes | Project Status | Most Recent FR Notice on Device Type |
|---|---|---|---|---|
| automated external defibrillator | 870.5310 | MKJ, NSA | Step 2 | Link |
| cardiovascular permanent pacemaker electrode | 870.3680(b) | DTB | Step 4 | Link |
| cranial electrotherapy stimulator | 882.5800 | JXK | Step 4 | Link |
| electroconvulsive therapy device | 882.5940 | GXC | Step 2 | Link |
| endosseous dental implant (blade-form dental implants) | 872.3640(b)(2) | NRQ | Step 2 | Link |
| external cardiac compressor | 870.5200 | DRM, LIX | Step 2 | Link |
| external counter-pulsating device | 870.5225 | DRN | Step 2 | Link |
| external pacemaker pulse generator | 870.3600 | DTE | Step 4 | Link |
| female condom | 884.5330 | OBY | Step 5 | Link |
| hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis | 888.3330 | KWA | Step 2 | Link |
| hip joint metal/metal semi-constrained, with cemented acetabular component, prosthesis | 888.3320 | JDL, LTO | Step 2 | Link |
| implantable pacemaker pulse generator | 870.3610 | DSZ, DXY | Step 4 | Link |
| implanted blood access device | 876.5540(b)(1) | MSD | Step 2 | Link |
| intra-aortic balloon and control system | 870.3535 | DSP, NKO | Step 2 | Link |
| iontophoresis device | 890.5525(b) | EGJ | Step 2 | Link |
| mandibular condyle prosthesis | 872.3960(c)2) | NEI | Step 2 | Link |
| membrane lung for long-term pulmonary support (i.e., ECMO) | 868.5610 | BYS | Step 2 | Link |
| nonroller-type cardiopulmonary bypass blood pump | 870.4360 | KFM | Step 2 | Link |
| pacemaker programmers | 870.3700 | KRG | Step 4 | Link |
| pacemaker repair or replacement material | 870.3710 | KFJ | Step 5 | Link |
| pedicle screw spinal system | 888.3070(b)(2) | NKB | Step 2 | Link |
| shortwave diathermy | 890.5290(b) | ILX | Step 2 | Link |
| sorbent hemoperfusion system | 876.5870 | FLD | Step 3 | Link |
| topical oxygen | 878.5650 | KPJ | Step 5 | Link |
| transilluminator for breast evaluation | 892.1990 | LEK | Step 4 | Link |
| ventricular bypass device | 870.3545 | OKR | Step 5 | Link |
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