[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