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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

Finalized 515 Projects

Year Device CFR Product Code Final
Classification
of Device		 Class III Reclassification
(Class III to
Class II or
Class I)
check mark Total check mark Total
2011 topical oxygen 878.5650 KPJ Final Rule1   3 check mark 1
female condom 884.5330 OBY Final Rule1 check mark  
pacemaker repair or replacement material 870.3710 KFJ Final Rule1 check mark  
ventricular bypass device 870.3545 OKR Final Rule1 check mark  
2012 implantable pacemaker pulse generator 870.3610 DSZ, DXY Final Rule1 check mark 3   0
pacemaker programmers 870.3700 KRG Final Rule1 check mark  
cardiovascular permanent pacemaker electrode 870.3680(b) DTB Final Rule1 check mark  
2013 temporary mandibular condyle reconstruction plate 872.4770 NEI Final Order
Guideline Document		   2 check mark 3
intra-aortic balloon and control system 870.3535 DSP Final Order2 check mark check mark
external counter-pulsating devices 870.5225 DRN Final Order2 check mark check mark
2014 transilluminator for breast evaluation 892.1990 LEK Final Order2 check mark 2   3
sorbent hemoperfusion system 876.5870 FLD Final Order2 check mark check mark
endosseous dental implant (blade-form) 872.3640 NRQ Final Order   check mark
implanted blood access 876.5540(b)(1) MSD Final Order
Guidance Document		   check mark
2015 automated external defibrillators 870.5310 MKJ, NSA Final Order check mark 2   2
nonroller-type blood pump 870.4360 KFM Final Order check mark check mark
Nonthermal Shortwave Therapy 890.5290(b) ILX Final Order   check mark
2016 Extracorporeal Circuit & Accessories for Long-term Respiratory /Cardiopulmonary Failure4 870.4100 BYS Final Order   2 check mark 5
Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prothesis 888.3330 KWA Final Order check mark  
Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis 888.3320 JDL Final Order check mark  
External pacemaker pulse generator 870.3600 DTE Final Order   check mark
External cardiac compressor5 870.5200 DRM Final Order   check mark
Iontophoresis 890.5525(b) EGJ Final Order   check mark
Thoracolumbosacral Pedicle Screw Systems, including semi-rigid systems6 888.3070(b)(2) NKB, NQP Final Order7   check mark
2018 electroconvulsive therapy device 882.5940 GXC Final Order2 check mark 1 check mark 1
2019 Cranial Electrotherapy Stimulator (CES)8 882.5800 JXK Final amendment; Final Order check mark 1 check mark 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.

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.

4 This was previously referred to as 'membrane lung for long-term pulmonary support' in 21 CFR 868.5610 and has been redesignated as noted.

5 A separate classification regulation for a subgroup of devices previously within this classification regulation, referred to as cardiopulmonary resuscitation (CPR) aids, was also created and these devices were also reclassified (21 CFR 870.5210).

6 This was previously referred to as 'pedicle screw systems' only and has been redesignated as noted. Semi-rigid systems were previously referred to as 'dynamic stabilization systems'

7 Federal Register Notice with correction of the compliance date for submitting 510(k) amendments.

8 FDA notes that the "ACTION" caption for this final order is styled as "Final amendment; final order," rather than "Final order." Beginning in December 2019, this editorial change was made to indicate that the document "amends" the Code of Federal Regulations. The change was made in accordance with the Office of Federal Register's (OFR) interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook.

 

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