News
05/28/1992
Device Tracking
T92-27 Sharon Snider
May 28, 1992 (301) 443-3285
FDA received hundreds of comments on a device tracking proposal
published in the March 27 Federal Register (see press release 92-9).
Because of the comments, FDA is reproposing these regulations. In addition,
Congress has proposed new legislation that would allow more time for
completion of rulemaking.
The reproposal retains the basic framework of the original proposal,
with certain revisions. The list of devices to be tracked was reduced from
35 to 21 because not all met the criteria for tracking. And the amount of
time a manufacturer has to provide FDA with a list of patient names and
locations when requested was extended from 3 days to 10 days.
The reproposal includes these provisions:
* Manufacturers of certain medical devices, including heart valves,
breast implants and defibrillators, would be required to adopt effective
systems for tracking their products from the manufacturer through the
distribution chain to the patient. The aim is to help protect consumers by
enabling manufacturers to locate people when a problem is discovered with
their device and advise them about what to do.
* The requirement is limited to permanent implants and life-sustaining
or life-supporting devices used outside of hospitals and doctors' offices,
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Page 2, T92-27, Device Tracking Regulations
whose failure would be likely to cause serious adverse health effects. Thus
the regulations apply only to medical devices that have the potential for
the most serious adverse health consequences and for which the potential for
recall is the greatest.
* Twenty-one types of devices from numerous manufacturers are affected
by the regulation, which was mandated by the Safe Medical Devices Act of
1990. Of these, 15 meet the statutory criteria for tracking, and FDA
designated six more because of the potential risk to the public health if
they should fail. In the future, FDA can designate additional devices to be
tracked.
* Manufacturers will be required to design a system appropriate to their
products. They will have to ensure that they can trace, identify and report
to FDA the patients' names and locations of devices within 10 working days.
Manufacturers will have to identify each device, set up a system to collect
and maintain information for the useful life of the device and audit the
data and functioning of the system periodically.
* No specific method of tracking is specified in the regulation, and
manufacturers have the option to use different methods to ensure collection
of information from patients or health care facilities, as long as the
methods are adequate. FDA envisions that often more than one means of data
collection may be necessary to ensure effective tracking. For example,
pre-addressed postcards given to patients to be returned to the manufacturer
can be used as long as the manufacturer also makes provisions to follow
patients for changes in names or addresses through an additional method.
Due to a special effective date provision in the Safe Medical Devices
Act, the proposed rule becomes a final rule on May 28. The final rule
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Page 3, T92-27, Device Tracking Regulations
implementation date is March 1, 1993, allowing manufacturers time to
establish effective tracking systems.
FDA issued the reproposal May 27, 1992, and on May 28 issued a document
with identical regulatory language termed a final rule. Both documents will
be published in the Federal Register May 29. The procedure was necessary
for technical reasons.
The public has 60 days to comment on the regulation. Comments may be
sent to Dockets Management Branch, FDA-305, Room 1-23, 12420 Parklawn Dr.,
Rockville, Md. 20857. Comments will be considered carefully in any further
revision of the regulation considered necessary by the agency.
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