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

DeviceCFRProduct CodesTasks CompletedRecent FDA
Information
automated external defibrillator870.5310MKJ, NSAA, B, C, DProposed Order
Panel Meeting
cranial electrotherapy stimulator882.5800JXKA, BWihdrawal
Panel Meeting
electroconvulsive therapy device882.5940GXCA, BPanel Meeting
external cardiac compressor870.5200DRM, LIXA, B, C, DProposed Order
Panel Meeting
external pacemaker pulse generator870.3600DTEA, B, CProposed Order
Panel Meeting
hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis888.3330KWAA, B, C, DProposed Order
hip joint metal/metal semi-constrained, with cemented acetabular component, prosthesis888.3320JDL, LTOA, B, C, DProposed Order
iontophoresis device890.5525(b)EGJA, B, CProposed Order
Panel Meeting
membrane lung for long-term pulmonary support (i.e., ECMO)868.5610BYSA, B, C, DProposed Order
Panel Meeting
nonroller-type cardiopulmonary bypass blood pump870.4360KFMA, B, C, DProposed Order
Panel Meeting
pedicle screw spinal system888.3070(b)(2)NKBA, BPanel Meeting
shortwave diathermy890.5290(b)ILXA, B, C, DProposed Order
Panel Meeting

Finalized 515 Projects

YearDeviceCFRProduct CodeFinal
Classification
of Device
Class IIIReclassification
(Class III to Class II or Class I)
check markTotalcheck markTotal
2011topical oxygen878.5650KPJFinal Rule1 3check mark1
female condom884.5330OBYFinal Rule1check mark 
pacemaker repair or replacement material870.3710KFJFinal Rule1check mark 
ventricular bypass device870.3545OKRFinal Rule1check mark 
2012implantable pacemaker pulse generator870.3610DSZ, DXYFinal Rule1check mark3 0
pacemaker programmers870.3700KRGFinal Rule1check mark 
cardiovascular permanent pacemaker electrode870.3680(b)DTBFinal Rule1check mark 
2013temporary mandibular condyle reconstruction plate872.4770NEIFinal Order
Guideline Document
 2check mark 3
intra-aortic balloon and control system870.3535DSPFinal Order2check markcheck mark
external counter-pulsating devices870.5225DRNFinal Order2check markcheck mark
2014transilluminator for breast evaluation892.1990LEKFinal Order2check mark2 3
sorbent hemoperfusion system876.5870FLDFinal Order2check markcheck mark
endosseous dental implant (blade-form)872.3640NRQFinal Order check mark
implanted blood access876.5540(b)(1)MSDFinal Order
Guidance Document3
 check mark

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.

2 Some devices have been classified in two different classes based on the device’s indications for use or technology.

3 CDRH has issued draft guidance on this topic. When finalized, this guidance will represent FDA’s current thinking on this topic.

Page Last Updated: 09/25/2014
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