[Federal Register Volume 62, Number 246 (Tuesday, December 23, 1997)]
[Proposed Rules]
[Pages 67011-67013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33372]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 /
Proposed Rules
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 801, 803, 804, 806, 807, 810, 820, 821, 1002, and 1020
[Docket No. 97N-0477]
RIN 0910-ZA09
Medical Devices; Refurbishers, Rebuilders, Reconditioners,
Servicers, and ``As Is'' Remarketers of Medical Devices; Review and
Revision of Compliance Policy Guides and Regulatory Requirements;
Request for Comments and Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
intention to review and, as necessary, to revise or to amend its
compliance policy guides and regulatory requirements relating to the
remarketing of used medical devices and the persons who refurbish,
recondition, rebuild, service, or remarket such devices. The agency is
considering these actions because it believes evolving industry
practices warrant reevaluation of current policy and the application of
certain regulatory requirements in order to ensure that particular
remarketed devices meet suitable performance requirements for their
intended uses, and are as safe as the originally marketed finished
device. FDA is soliciting comments, proposals for alternative
regulatory approaches, and information on these issues. In a future
issue of the Federal Register, FDA will announce an open meeting of the
Good Manufacturing Practices (GMP) Advisory Committee concerning these
matters.
DATES: Written comments by March 23, 1998.
ADDRESSES: Submit written comments 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
Medical device marketing has always involved a certain amount of
remarketing of used medical devices that were refurbished, rebuilt,
serviced, reconditioned, cosmetically enhanced or marketed ``as is''
for further use. Under regulations issued by FDA for medical devices,
including radiation emitting electronic products, at parts 801, 803,
804, 806, 807, 810, 820, 821, 1002, and 1020 (21 CFR parts 801, 803,
804, 806, 807, 810, 820, 821, 1002, and 1020), most such processing of
used devices falls within the definition of manufacturing or is
identified among activities performed by manufacturers, thereby
subjecting remarketers to the same regulatory requirements as other
manufacturers. These requirements include: labeling (part 801); medical
device reporting (parts 803 and 804); corrections and removals (part
806); registration, listing and premarket notification (part 807);
physician, patient notification and recall remedies (part 810); current
good manufacturing practices (part 820); device tracking (part 821);
and for electronic devices, electronic product reports (part 1002); and
electronic product performance standards (part 1020).
Remarketing used devices may consist of activities that
significantly change the finished device's performance or safety
specifications, or intended use. These types of activities constitute
``remanufacturing'' as defined in the Quality System regulation (QS)
(also known as the current good manufacturing practice (CGMP)
regulation) (Sec. 820.3(w)). Remarketing used devices can also consist
of activities that do not significantly change the finished device's
performance or safety specifications, or intended use. These activities
may consist of refurbishing, reconditioning, rebuilding, servicing the
device, or merely selling the device ``as is.'' Current guidance,
discussed further in section II of this document, describes whom FDA
considers a reconditioner or rebuilder of a device. FDA has not issued
regulations or guidance defining what activities are considered
``servicing'' or ``refurbishing.''
II. Current Compliance Policy Guides Relating to Remarketers Who
Are Considered Reconditioners, Rebuilders, and X-Ray Tube Reloaders
FDA has issued two compliance policy guides (CPG's) that relate to
persons who remarket devices, but do not change the finished device's
intended use. On November 1, 1981, FDA issued CPG 7133.20, which set
forth the agency's position that ``adequate enforcement can be
effectively accomplished'' by considering reloaders of x-ray tube
housing assemblies to be assemblers of x-ray components if a reloaded
x-ray tube housing assembly is the only finished device produced by the
firms. This CPG further stated reloaders must retain complaint files,
injury reports, and failure analysis records that must be available for
inspection by the agency. FDA has exercised its enforcement discretion
with respect to establishment registration and device listing
requirements under section 510 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360) for such firms.
On December 29, 1987, FDA issued CPG 7124.28 to address the
application of certain requirements of the act and its implementing
regulations to firms that acquire and process used devices for
remarketing purposes. The agency identified the reconditioner/rebuilder
of a medical device as ``a person or firm that acquires ownership of
used medical devices and restores and/or refurbishes these (devices) to
the device manufacturer's original or current specifications, or new
specifications, for purposes of resale or commercial distribution.''
In CPG 7124.28, the agency stated that reconditioners/rebuilders of
medical devices must comply with: The registration, and premarket
notification requirements of the act (section 510) and implementing
regulatory requirements (part 807); the labeling requirements of the
act (section 502) and applicable regulatory requirements (part 801);
the CGMP requirements of the act (section 520) and implementing
regulatory requirements (part 820); and, the medical device reporting
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requirements of the act (section 519) and implementing regulatory
requirements (part 803). FDA intends to revise this CPG based on FDA's
experience in this area and the comments received to this advance
notice of proposed rulemaking (ANPR).
III. Reasons for Review
In the Federal Register of October 7, 1996 (61 FR 52602), FDA
issued a revised QS regulation which set forth CGMP requirements for
medical devices (part 820). The preamble of the October 7, 1996, QS
regulation acknowledged that:
[CPG] 7124.28 contains the agency's policy regarding the
provisions of the act and regulations with which persons who
recondition or rebuild used devices are expected to comply. This CPG
is in the process of being revised in light of FDA's experience in
this area. FDA is not including the terms ``servicer'' or
``refurbisher,'' as they relate to entities outside the control of
the original equipment manufacturer, in this [QS] final regulation,
even though it believes that persons who perform such functions meet
the definition of manufacturer.
(61 FR 52602 at 52610)
FDA further advised that, ``[b]ecause of a number of competitive and
other issues, including sharply divided views among members the GMP
Advisory Committee at the September 1995 meeting, FDA has elected to
address application of the GMP requirements to persons who perform
servicing and refurbishing functions outside the control of the
original manufacturer in a separate rulemaking later this year'' Id.
In addition to the concerns raised in the QS/CGMP rulemaking
process relating to the applicability of CGMP's to remarketers, issues
have been raised relating to the applicability of other regulatory
requirements to remarketers. In response to these concerns, FDA has
attempted to learn more about the concerns relating to remarketers. In
1994, FDA began discussing issues related to remarketers with the
International Association of Medical Equipment Remarketers (IAMER).
Beginning in 1994 and continuing through IAMER's April 10 to 12, 1997,
meeting, representatives of the FDA's Center for Devices and
Radiological Health have attended, and on occasion made presentations
at, various meetings and conferences of IAMER membership firms.
Through exchanges at these meetings and correspondence with IAMER's
Regulatory Affairs Committee, FDA has preliminarily noted that rising
costs and health care expenses have apparently contributed to expanded
sales of a growing variety of remarketed devices. Much of this activity
is occurring outside the control of the original equipment
manufacturer. FDA also tentatively concluded that a significant number
of firms that have been refurbishing or otherwise remarketing
electronic radiation emitting medical devices are unaware of FDA's
compliance policy, and the applicable regulations and statutory
requirements, such as the filing of initial and other reports under
parts 1002 and 1020, with respect to their activities.
IV. Proposed Definitions of Remarketing Activities That Constitute
Refurbishing, ``As Is'' Remarketing, and Servicing
As stated in section II of this document, FDA has issued guidance,
which is being considered for revision, that describes who FDA
considers to be ``reconditioners'' and ``rebuilders.'' FDA has not
issued regulations or guidance defining what persons are considered to
be ``refurbishers,'' ``as is'' remarketers, or ``servicers.'' These
terms have been difficult to define and at times have been used
interchangeably. Compliance Policy Guide 7124.28 states only that FDA
considers rebuilders or reconditioners to be persons who have acquired
ownership of the devices and conduct refurbishing activities.
FDA is soliciting comments on whether to propose definitions, as
described in the following three paragraphs, of types of remarketers,
either in guidance or in a regulation, that may or may not relate to
the ownership of the devices. Accordingly, FDA is soliciting comments
on whether it should propose by regulation, or issue by guidance, the
following definitions or a variation of these definitions to describe
remarketing activities that do not significantly change a finished
device's performance or safety specifications or intended use.
Refurbishers: persons who, for the purpose of resale or
redistribution, visually inspect, functionally test and service
devices, as may be required, to demonstrate that the device is in good
repair and performing all the functions for which it is designed. The
device may or may not be cosmetically enhanced. Preventive maintenance
procedures may or may not be performed. Refurbishers do not
significantly change a finished device's performance or safety
specifications, or intended use.
``As Is'' Remarketers: for the purpose of resale or redistribution,
the operational condition of the device is unknown. The extent to which
the device meets the operational requirements must be determined by the
user prior to patient exposure. The device may or may not be
cosmetically enhanced. ``As Is'' remarketers do not change a finished
device's performance or safety specifications, or intended use.
Servicers: persons who repair a device to return it to the
manufacturer's fitness for use specifications, and perform the
manufacturer's recommended scheduled preventive maintenance. Servicers
do not significantly change a finished device's performance or safety
specifications, or intended use.
FDA believes that these definitions encompass activities that do
not significantly change the finished device's performance or safety
specifications or intended use.
V. Revisions Under Consideration
In light of evolving industry practices, and the concerns raised by
the GMP Advisory Committee, industry, and others described previously,
FDA is reevaluating the application of various regulatory controls to
remarketers who do not significantly change a finished device's
performance or safety specifications, or intended use, and is
reassessing the degree of regulatory control necessary to ensure the
protection of the public health. FDA intends to evaluate the current
regulatory approach with respect to remarketers who are refurbishers,
``as is'' remarketers, and servicers, as defined in this document, and
is soliciting comments on whether FDA should retain the current
regulatory approach, or whether the agency should use alternative
approaches to regulate these types of remarketers.
The agency believes that any regulatory approach for these types of
remarketers should, at a minimum, include compliance with requirements
concerning: Representations of quality under section 501(c) of the act
(21 U.S.C. 351(c)); false or misleading labeling under section 502 of
the act (21 U.S.C. 352), and part 801; notification and recall
provisions under section 518 of the act (21 U.S.C. 360h), and part 810;
corrections and removal reporting requirements under section 519(f) of
the act (21 U.S.C. 360i(f)), and part 806; medical device reporting
under section 519(a) of the act, and parts 803 and 804; tracking
requirements under section 519(e) of the act, and part 821; and
radiological health requirements under sections 532 through 542 of the
act (21 U.S.C. 360ii through 360ss), including records and initial
reporting requirements under part 1002, and standard requirements under
part 1020.
Accordingly, FDA requests information on the following issues
relating to remarketing activities that do not significantly change the
finished
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device's performance or safety specifications or intended uses.
(1) Has FDA appropriately defined the terms, ``refurbisher,'' ``as
is'' remarketers, and ``servicers''? If not, what changes to these
definitions should be made?
(2) What evidence exists regarding actual problems with the safety
and/or performance of remarketed devices that are the result of the
remarketing? Specific examples should be submitted.
(3) What is the appropriate level of regulatory controls that
should be applied to persons who remarket devices?
(4) Should refurbishers, ``as is'' remarketers, and servicers be
subject to the same or different regulatory requirements?
In addition, FDA is specifically considering whether to propose
rulemaking regarding modified registration, listing, and CGMP
requirements for these types of remarketers, or whether to make some or
all of the these three controls voluntary. For example, the agency
could propose that refurbishers and/or servicers be required to
register and list with FDA (part 807), and comply with certain CGMP
requirements, such as quality system requirements (part 820, subpart
B), production and process controls (part 820, subpart G), acceptance
activities (part 820, subpart H), corrective and preventive action
(part 820, subpart J), labeling and packaging control ( part 820,
subpart K), and records (part 820, subpart M). Alternatively, the
agency could propose that refurbishers and/or servicers be required to
register and list, but comply only with CGMP requirements for
maintaining complaint files (Sec. 820.198(a)) and conducting failure
analyses (Sec. 820.198(b) and (c)). In making comments relating to the
regulatory approaches, comments should indicate whether their comments
relate to refurbishers, ``as is'' remarketers, and/or servicers, as
described in section IV of this document. Other regulatory approaches
may be proposed by the agency or by the comments which, if implemented,
would require the issuance of new guidance documents, or consist of
changes to current regulations or changes to existing guidances CPG
7124.28 and CPG 7133.20.
VI. Comments
The agency will consider any comments submitted in response to this
ANPR, or comments relating to the reevaluation of agency guidances,
including CPG's 7124.28 and 7133.20. FDA will consider the record of
any public meetings or any advisory committee meetings, along with
comments, proposals and other information received, when deciding
whether to issue or revise agency guidance or modify any existing
regulations.
Interested persons may, on or before March 23, 1998 submit to
Dockets Management Branch (address above) written comments regarding
this ANPR. 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.
Received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday. FDA does not anticipate granting requests
for extension to this 90-day comment period.
Dated: December 3, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33372 Filed 12-22-97; 8:45 am]
BILLING CODE 4160-01-F