[Federal Register Volume 63, Number 42 (Wednesday, March 4, 1998)]
[Notices]
[Pages 10638-10640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5520]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0517]


Medical Devices; Device Tracking; New Orders to Manufacturers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
agency has issued new orders to manufacturers of devices that were 
subject to tracking. These new orders became effective on February 19, 
1998, and require manufacturers to continue tracking the devices under 
the revised tracking provisions of the recently enacted Food and Drug 
Administration Modernization Act of 1997 (FDAMA). FDAMA allows the 
agency discretion in issuing orders to manufacturers to track devices 
that meet certain criteria. FDA is soliciting comments on what factors 
should be considered in exercising its discretion in determining 
whether the agency should not track a particular device, even though it 
meets the statutory criteria. FDA specifically is requesting comments 
on whether there are factors that FDA should consider in exercising its 
discretion in releasing certain devices listed in this notice from 
tracking requirements. Elsewhere in this issue of the Federal Register, 
FDA is announcing the availability of a guidance that addresses device 
tracking under FDAMA, including the application of certain requirements 
under the current tracking regulations.

DATES:  Written comments concerning this notice may be received by May 
4, 1998.

ADDRESSES: Written comments may be submitted to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Casper E. Uldriks, Center for Devices 
and Radiological Health (HFZ-300), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-4692.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Safe Medical Device Act of 1990 (the SMDA) added tracking 
provisions to the Federal Food, Drug, and Cosmetic Act (the act) by 
adding new section 519(e) of the act (21 U.S.C. 360i(e)). As added by 
the SMDA, section 519(e)(1) of the act required the adoption of a 
method of tracking, even if FDA did not issue an order. Specifically, 
any person registered under section 510 of the act (21 U.S.C. 360), and 
engaged in the manufacture of a device, had to track the device if the 
failure of that device would be reasonably likely to have serious 
adverse health consequences, and the device was either a permanently 
implantable device or a life sustaining or life supporting device used 
outside a device user facility. Section 519(e)(2) of the act also 
authorized FDA to ``designate'' other devices that must be tracked.
    FDA issued regulations implementing tracking requirements in the 
Federal Register of August 16, 1993 (58 FR 43442). The regulations 
became effective on August 29, 1993, and are codified in part 821 (21 
CFR part 821). Under tracking provisions established by the SMDA, 
manufacturers had the responsibility to identify devices that met the 
statutory criteria for tracking. For illustrative purposes, the agency 
set out in Sec. 821.20(b)(1) and (b)(2) a list of example devices it 
considered subject to mandatory tracking under section 519(e)(1) of the 
act. Devices designated for tracking by FDA under section 519(e)(2) of 
the act were listed in Sec. 821.20(c).
    FDAMA was enacted on November 21, 1997. Section 211 of FDAMA 
amended section 519(e)(1) of the act to authorize FDA, in its 
discretion, to issue orders that require a manufacturer to track a 
class II or class III device if the failure of the device would be 
reasonably likely to have serious adverse health consequences, or the 
device is intended to be implanted in the human body for more than 1 
year, or is life sustaining or life supporting and used outside a 
device user facility. Section 519(e)(2) of the act, as amended by 
FDAMA, provides that patients receiving a tracked device may refuse to 
provide their name, address, social security number, or other 
identifying information, for tracking purposes. Accordingly, tracking 
may be required

[[Page 10639]]

under section 519(e), as amended by FDAMA, only if FDA issues an order 
and only if the criteria described previously are met. FDAMA tracking 
provisions became effective on February 19, 1998.

II. Implementation of FDAMA Tracking Authority

    FDA has initiated the measures identified in section II of this 
document to implement the tracking authority given to the agency under 
section 519(e) of the act, as amended by FDAMA.

A. Manufacturer Notification/Public Meeting

    On December 19, 1997, FDA sent letters to manufacturers identified 
as having responsibilities to track devices under section 519(e) of the 
act. These letters advised the firms that FDAMA would implement 
important statutory changes in these areas and that FDA had announced 
in the Federal Register of December 18, 1997 (62 FR 66373), that it 
would conduct a public meeting on January 15, 1998, to discuss such 
changes. The letter also advised that existing device tracking 
requirements imposed by previously issued FDA regulations or FDA orders 
would remain in effect, until FDA notified a firm of any changes in its 
responsibilities.
    At the January 15, 1998, public meeting held in Rockville, MD, 
written and oral comments were received from consumer groups, 
clinicians, manufacturers and device industry associations. These 
comments ranged from considering clinical management issues, and the 
use of alternative tracking mechanisms, to considering the likelihood 
of device failure.

B. Issuance of Tracking Orders

    On February 11, 1998, FDA issued orders to manufacturers who would 
be required to track their devices under section 519(e), as revised by 
FDAMA. These orders became effective on February 19, 1998. The devices 
subject to these new orders are the types of devices currently 
identified in the agency's tracking regulations at 21 CFR 821.20(b)(1), 
(b)(2), and (c), except that arterial stents and intraocular lenses 
have been added. FDA has determined that these devices meet the 
criteria under revised section 519(e) of the act. These devices are as 
follows:

 Table 1.--Devices Meeting the Criteria Under Revised Section 519(e) of 
                                 the Act                                
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    21 CFR Section                       Classification                 
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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(b)             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                      
(no cite)               Arterial stents (used in coronary arteries or   
                         peripheral arteries)                           
886.3600                Intraocular lens                                
868.2375                Breathing frequency monitors (apnea monitors)   
                         (including ventilatory efforts monitors)       
868.5895                Continuous ventilator                           
870.5300                DC-defribrillator and paddles                   
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 pump                                   
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C. FDA Review/Reconsideration of Devices Requiring Tracking

    Although FDA has issued orders to subject all of the devices 
described previously to tracking requirements under section 519(e) of 
the act, as revised by FDAMA, FDA recognizes that the new law provides 
the agency with discretion to not require tracking of devices that meet 
the statutory criteria. FDA believes that certain factors may indicate 
that tracking for some devices, even though they meet the statutory 
criteria under section 519(e) of the act, may not be necessary to 
protect the public health. Accordingly, FDA is soliciting comments on 
what factors FDA should consider in exercising its discretion to 
require, or not to require, tracking of those devices that meet the 
statutory criteria stated in section 519(e) of the act. Comments should 
not merely identify what devices that meet the statutory tracking 
criteria should or should not be tracked, but should fully address the 
factors that should be relevant in the agency's exercise of discretion. 
After reviewing the comments received in response to this document, FDA 
will determine what factors should be considered in exercising its 
discretion. After determining what those factors should be, FDA will 
rescind any orders issued under section 519(e) of the act, if the 
agency determines that tracking is not necessary to protect the public 
health.
    The agency has requested comments on the implementation of tracking 
requirements enacted by FDAMA. After considering the: (1) Agency's 
experience; (2) information provided by the public at the January 15, 
1998, meeting; and (3) written submissions received afterwards, the 
agency has

[[Page 10640]]

tentatively identified several products that are subject to the 
February 1998, tracking orders for which there may be factors that may 
be considered in the agency's exercise of discretion not to track a 
particular device, even though it meets the statutory criteria. These 
devices are the following:

Table 2.--Previously ``Mandated'' Devices--Permanently Implanted Devices
------------------------------------------------------------------------
    21 CFR Section                       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)               Interarticular disc prosthesis (interpositional 
                         implant)                                       
870.3800                Annuloplasty ring                               
878.3720                Tracheal Prosthesis                             
(no cite)               Arterial stents (used in coronary arteries or   
                         peripheral arteries)                           
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               Table 3.--Previously ``Designated'' Devices              
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    21 CFR Section                       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 device    
880.575                 Infusion pump (i.e., those designated and       
                         labeled for use exclusively for fluids with low
                         potential risks, e.g., enteral feeding, anti-  
                         infectives)                                    
------------------------------------------------------------------------

The agency invites comments on these devices, as well as any other 
devices that should be added or deleted from the list of those devices 
subject to tracking requirements.

III. Comments

    Interested persons may, by or before May 4, 1998 submit to the 
Dockets Management Branch (address above) written comments concerning 
this notice. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. The notice and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 25, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-5520 Filed 2-27-98; 3:14 pm]
BILLING CODE 4160-01-F