[Federal Register Volume 64, Number 127 (Friday, July 2, 1999)]
[Notices]
[Pages 36019-36020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16938]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-2100]
Agency Emergency Processing Under OMB Review; Survey of
Manufacturers of Computer-Controlled Potentially High Risk Medical
Devices Regarding Year 2000 Status
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for emergency processing under the
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of
information concerns a survey of manufacturers of computer-controlled
potentially high risk medical devices to ensure that they have properly
assessed the Year 2000 (Y2K) status of their computer-controlled
medical devices and developed and properly validated appropriate
upgrades to correct any Y2K problem for those devices. On June 10,
1999, FDA testified before the Bennett-Dodd subcommittee on Y2K. The
outcome of the hearing was directed by Congress to proceed as quickly
as possible on the audit of these medical devices. Therefore, FDA is
requesting OMB approval by July 9, 1999.
DATES: Submit written comments on the collection of information by July
6, 1999.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Stewart Crumpler, Center for Devices
and Radiological Health (HFZ-340), 2094 Gaither Rd., Rockville, MD
20850, 301-594-4659, ext. 119.
SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of
this proposed collection of information under section 3507(j) of the
PRA (44 U.S.C. 3507(j)) and 5 CFR 1320.13. This information is needed
immediately to respond to concerns from the General Accounting Office
and others in the health care sector that FDA provide, as soon as
possible, independent assurance that the manufacturers of computer-
controlled potentially high risk medical devices have properly assessed
the Y2K status of their computer-controlled medical devices and that
they have developed and properly validated appropriate upgrades to
correct any Y2K problem for those devices. The proposed study must be
completed no later than September 6, 1999, in order to provide health
care facilities and others with timely assurances that they need to
complete their own assessments of their vulnerability to Y2K problems
and to take corrective actions, if necessary, well in advance of
January 1, 2000. In addition, if the data show previously undisclosed
problems with manufacturers' Y2K assessments of computer-controlled
potentially high risk devices, that information will allow the
Government to undertake further actions, as necessary, to correct
problems that might exist in order to protect the public health. It is
vital that there be no Y2K failures of computer-controlled potentially
high risk medical devices. The use of normal clearance procedures would
not provide timely assurance that manufacturers are complying with the
quality system regulations and, if problems are found, would not allow
time to enact corrective actions in advance of January 1, 2000.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of
[[Page 36020]]
FDA's estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology.
Title: Survey of Manufacturers of Computer-Controlled Potentially
High Risk Medical Devices Regarding Year 2000 Status
Under section 201 of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 321 et seq.), a medical device is adulterated if not
designed and manufactured in accordance with good manufacturing
practices specified in the quality system regulations in 21 CFR part
820. Among other provisions, this regulation requires that
manufacturers take action to correct an identified quality problem and
to prevent its recurrence. This regulation also requires that devices
be developed in accordance with specified design controls, including
validation of the change. From inspectional experience for all types of
devices and device issues, the Center for Devices and Radiological
Health believes that the quality systems of manufacturers and the
potential regulatory sanctions of the act are sufficient to ensure that
manufacturers will take responsible action to correct serious Y2K
problems in their devices. In addition to possible FDA enforcement
action, manufacturers have very strong business and legal incentives to
make sure any Y2K-related upgrade is safe and provides the correct
performance needed for the device. These incentives include customer
satisfaction and the potential liability that would result from an
incorrect or inadequate upgrade to a product that results in harm to a
patient. Also relevant is the added expense and adverse publicity
associated with a device recall that would result when a problem in
uncovered and corrections have to be implemented.
However, because of the unprecedented potential for adverse impact
on medical devices by Y2K problems, FDA believes it is both necessary
and prudent to validate these assumptions by conducting a limited
survey of manufacturers of the types of medical devices that pose the
greatest potential risk to patients. To this end, FDA has developed a
list of computer-controlled potentially high risk medical devices, as
well as a list of the manufacturers who produce these types of devices.
FDA will survey a sample drawn from the list of manufacturers to ensure
that manufacturers have: (1) Properly assessed the Y2K status of their
computer-controlled medical devices; (2) identified all devices subject
to a possible date related Y2K problem; (3) applied risk analyses to
determine the appropriate remedial action to be undertaken; (4)
validated any new hardware or software developed to fix the identified
Y2K problem; and (5) properly communicated information on the Y2K
remediation to affected customers. This applies to all devices still in
use in health care facilities--both current production and any
previously distributed devices.
A selected sample of the manufacturers of computer-controlled
potentially high-risk medical devices will be asked to voluntarily
participate in the survey. An FDA contractor employing experienced
software quality engineers, or persons with similar qualifications,
will schedule a survey at the manufacturer's site. During the survey,
the FDA contractor will review the design records of the manufacturer,
examining the adequacy of the firm's procedures for Y2K assessments
and, if applicable, Y2K corrective actions. The survey will also
provide reasonable assurance that Y2K assessment and, if applicable,
remediation procedures have been consistently applied to all currently
produced or previously manufactured high risk devices.
This survey is not intended to be comprehensive, but is intended to
cover a representative sample of the manufacturers of computer-
controlled potentially high risk medical devices. The results of the
survey will provide a basis for continued confidence in manufacturers'
capability to produce a supply of Y2K safe medical devices in
compliance with the quality system regulation as well as confidence in
the general accuracy of manufacturers' claims in the FDA operated
Federal Y2K Biomedical Equipment Clearinghouse.
Respondents: Manufacturers of Computer-Controlled Potentially High
Risk Medical Devices
FDA estimates the burden of this collection as follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
No. of Respondents Frequency per Total Annual Hours per Total Hours
Response Responses Response
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80 1 80 43 3,440
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
These estimates are based on FDA's experience in conducting field
investigations and audits. In order to more sharply focus the agency
efforts related to the possible impact of the Y2K date problem on
medical devices, FDA has developed a list of types of computer-
controlled, potentially high-risk medical devices that have the
potential for the most serious consequences for the patient should they
fail. Inclusion of a type of device on this list does not mean that all
devices of this type have a date related problem (are Y2K noncompliant)
or, if they are Y2K noncompliant, that they necessarily pose a
significant risk to patients. Rather, this list includes those types of
devices that could pose a risk to patients if the date-related failure
affects the function or operation of the device. Using agency data
bases, FDA then determined the manufacturers that produce these types
of medical devices. The sample to be surveyed was drawn from this pool
of manufacturers. FDA estimates that it will take manufacturers an
average of 43 hours to prepare for and participate in the survey. This
includes time to make records available to the surveyor at the
manufacturer's site; participate in interviews and briefings, if
necessary; and to review and respond to the surveyor's report, if
desired. These estimates include allowance for variance in the number
of high risk devices produced by a individual manufacturer.
Dated: June 29, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-16938 Filed 7-1-99; 8:45 am]
BILLING CODE 4160-01-F
