About FDA
515 Project Status
Task A: FDA collects existing information and assesses the risks and benefits (See Docket FDA-2009-M-0101 for information submitted to FDA by manufacturers of these device types)
Task B: FDA convenes a meeting of the advisory committee (panel) to request input on the classification of the device type.
Task C: FDA issues proposed order, which proposes classification of device type into Class I, II, or III
Task D: FDA reviews and considers comments provided
Task E: FDA issues final order, which finalizes classification of device type into Class I, II, or III
| Device | CFR | Product Codes | Tasks Completed | Recent FDA Information |
|---|---|---|---|---|
| automated external defibrillator | 870.5310 | MKJ, NSA | A, B, C | Proposed Order Panel Meeting |
| cranial electrotherapy stimulator | 882.5800 | JXK | A, B, C | Proposed Order Panel Meeting |
| electroconvulsive therapy device | 882.5940 | GXC | A, B | Panel Meeting |
| endosseous dental implant (blade-form dental implants) | 872.3640(b)(2) | NRQ | A, C | Proposed Order Panel Meeting |
| external cardiac compressor | 870.5200 | DRM, LIX | A, C | Proposed Order |
| external counter-pulsating device | 870.5225 | DRN | A, B, C | Proposed Order Panel Meeting |
| external pacemaker pulse generator | 870.3600 | DTE | A | Proposed Rule Guidance Document |
| hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis | 888.3330 | KWA | A, B, C | Proposed Order |
| hip joint metal/metal semi-constrained, with cemented acetabular component, prosthesis | 888.3320 | JDL, LTO | A, B, C | Proposed Order |
| implanted blood access device | 876.5540(b)(1) | MSD | A | Proposed Rule Guidance Document Panel Meeting |
| intra-aortic balloon and control system | 870.3535 | DSP, NKO | A, B | Panel Meeting |
| iontophoresis device | 890.5525(b) | EGJ | A | |
| mandibular condyle prosthesis | 872.3960(c)2) | NEI | A, B, C | Proposed Order Special Controls Guideline |
| membrane lung for long-term pulmonary support (i.e., ECMO) | 868.5610 | BYS | A, C | Proposed Order |
| nonroller-type cardiopulmonary bypass blood pump | 870.4360 | KFM | A, B | Panel Meeting |
| pedicle screw spinal system | 888.3070(b)(2) | NKB | A, B | Panel Meeting |
| shortwave diathermy | 890.5290(b) | ILX | A, B | Proposed Rule Panel Meeting |
| sorbent hemoperfusion system | 876.5870 | FLD | A, B, C | Proposed Order Panel Meeting |
| transilluminator for breast evaluation | 892.1990 | LEK | A, B, C | Panel Meeting Proposed Order |
Finalized 515 Projects
| Device | CFR | Product Codes | Final Classification of Device |
|---|---|---|---|
| cardiovascular permanent pacemaker electrode | 870.3680(b) | DTB | Final Rule(1) |
| female condom | 884.5330 | OBY | Final Rule(1) |
| implantable pacemaker pulse generator | 870.3610 | DSZ, DXY | Final Rule(1) |
| pacemaker programmers | 870.3700 | KRG | Final Rule(1) |
| pacemaker repair or replacement material | 870.3710 | KFJ | Final Rule(1) |
| topical oxygen | 878.5650 | KPJ | Final Rule(1) |
| ventricular bypass device | 870.3545 | OKR | Final Rule(1) |
Please visit the 515 Initiative Website for more information about the program.
(1) The classification of this device was finalized prior enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012.
