[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]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

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.

========================================================================


Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / 
Proposed Rules

[[Page 67011]]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

[[Page 67012]]

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

[[Page 67013]]

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