[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
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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) 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
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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)
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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