[Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR821.20] [Page 153-154] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS--Table of Contents Subpart B--Tracking Requirements Sec. 821.20 Devices subject to tracking. (a) A manufacturer of any device the failure of which would be reasonably likely to have a serious adverse health consequence, that is either a life-sustaining or life-supporting device used outside of a device user facility or a permanently implantable device, or a manufacturer of any other device that FDA, in its discretion, designates for tracking, shall track that device in accordance with this part. (b) Manufacturers have the responsibility to identify devices that meet the criteria for tracking and to initiate tracking. By way of illustration and to provide guidance, FDA has set out below a list of example devices it regards as subject to tracking under the criteria set forth in this regulation. (1) Permanently implantable devices. ------------------------------------------------------------------------ 21 CFR Classification ------------------------------------------------------------------------ 870.3450 Vascular graft prosthesis of less than 6 millimeters diameter 870.3460 Vascular graft prosthesis of 6 millimeters and greater diameter (no cite) Total temporomandibular joint prosthesis. (no cite) Glenoid fossa prosthesis. (no cite) Mandibular condyle prosthesis. (no cite) Interarticular disc prosthesis (interpositional implant). 870.3545 Ventricular bypass (assist) device 870.3610 Implantable pacemaker pulse generator 870.3680 Cardiovascular permanent pacemaker electrode 870.3800 Annuloplasty ring 870.3925 Replacement heart valve (no cite) Automatic implantable cardioverter/defibrillator 878.3720 Tracheal prosthesis 882.5820 Implanted cerebellar stimulator 882.5830 Implanted diaphragmatic/phrenic nerve stimulator (no cite) Implantable infusion pumps ------------------------------------------------------------------------ (2) Life-sustaining or life-supporting devices used outside device user facilities [[Page 154]] ------------------------------------------------------------------------ 21 CFR Classification ------------------------------------------------------------------------ 868.2375 Breathing frequency monitors (apnea monitors) (including ventilatory efforts monitors) 868.5895 Continuous ventilator 870.5300 DC-defibrillator and paddles ------------------------------------------------------------------------ (c) FDA designates the following devices as subject to tracking. Manufacturers must track these devices in accordance with this part. ------------------------------------------------------------------------ 21 CFR Classification ------------------------------------------------------------------------ 876.3350 Penile inflatable implant 878.3530 Silicone inflatable breast prosthesis 878.3540 Silicone gel-filled breast prosthesis 876.3750 Testicular prosthesis, silicone gel-filled (no cite) Silicone gel-filled chin prosthesis (no cite) Silicone gel-filled angel chik reflux valve 880.5725 Infusion pumps ------------------------------------------------------------------------ (d) FDA, when responding to premarket notification submissions and approving premarket approval applications, will notify the sponsor that FDA believes the device meets the criteria of section 519(e)(1) and therefore should be tracked. FDA will also, after notifying the sponsor, publish a notice in the Federal Register announcing that FDA believes a new generic type of device is subject to tracking and soliciting comment on FDA's position. If the device is a new generic type of device not already on the example list above, FDA will add it to this list. [58 FR 43447, Aug. 16, 1993, as amended at 58 FR 43455, Aug. 16, 1993; 59 FR 15052, Mar. 31, 1994.]