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
(Class III to
Class II or
|2011||topical oxygen||878.5650||KPJ||Final Rule1||3||1|
|female condom||884.5330||OBY||Final Rule1|
|pacemaker repair or replacement material||870.3710||KFJ||Final Rule1|
|ventricular bypass device||870.3545||OKR||Final Rule1|
|2012||implantable pacemaker pulse generator||870.3610||DSZ, DXY||Final Rule1||3||0|
|pacemaker programmers||870.3700||KRG||Final Rule1|
|cardiovascular permanent pacemaker electrode||870.3680(b)||DTB||Final Rule1|
|2013||temporary mandibular condyle reconstruction plate||872.4770||NEI||Final Order
|intra-aortic balloon and control system||870.3535||DSP||Final Order2|
|external counter-pulsating devices||870.5225||DRN||Final Order2|
|2014||transilluminator for breast evaluation||892.1990||LEK||Final Order2||2||3|
|sorbent hemoperfusion system||876.5870||FLD||Final Order2|
|endosseous dental implant (blade-form)||872.3640||NRQ||Final Order|
|implanted blood access||876.5540(b)(1)||MSD||Final Order
|2015||automated external defibrillators||870.5310||MKJ, NSA||Final Order||2||2|
|nonroller-type blood pump||870.4360||KFM||Final Order|
|Nonthermal Shortwave Therapy||890.5290(b)||ILX||Final Order|
|2016||Extracorporeal Circuit & Accessories for Long-term Respiratory /Cardiopulmonary Failure4||870.4100||BYS||Final Order||2||5|
|Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prothesis||888.3330||KWA||Final Order|
|Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis||888.3320||JDL||Final Order|
|External pacemaker pulse generator||870.3600||DTE||Final Order|
|External cardiac compressor5||870.5200||DRM||Final Order|
|Thoracolumbosacral Pedicle Screw Systems, including semi-rigid systems6||888.3070(b)(2)||NKB, NQP||Final Order7|
|2018||electroconvulsive therapy device||882.5940||GXC||Final Order2||1||1|
|2019||Cranial Electrotherapy Stimulator (CES)8||882.5800||JXK||Final amendment; Final Order||1||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'
7Federal 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.