[Federal Register Volume 63, Number 233 (Friday, December 4, 1998)]
[Notices]
[Pages 67076-67078]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-32249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0477]


Medical Devices; Reconditioners, Rebuilders of Medical Devices; 
Revocation of Compliance Policy Guide; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is revoking Compliance 
Policy Guide (CPG) 7124.28 because application of current good 
manufacturing practice (CGMP) requirements to ``reconditioners/
rebuilders'' of used medical devices does not comport with definitions 
in the quality system (QS) regulation or guidance in the final rule 
that applies CGMP requirements to ``manufacturers'' and 
``remanufacturers.'' Because ``reconditioners/rebuilders'' are 
specifically excluded from the definition of ``manufacturer'' or 
``remanufacturer'' in the QS regulation, guidance in the CPG on the 
applicability of registration, listing, and other statutory and 
regulatory requirements to ``reconditioners/rebuilders'' does not 
represent current agency thinking. In the advance notice of proposed 
rulemaking (ANPRM), published in the December 23, 1997, Federal 
Register, FDA announced its intention to consider identifying the used 
device market, for regulatory purposes, in terms of ``refurbishers,'' 
``as-is remarketers,'' and ``servicers'' whose activities do not 
significantly change the safety, performance, or use of a device, and 
to examine alternative approaches for regulating these firms. Pending 
the issuance of a rule or guidance setting forth FDA's current 
position, CPG 7124.28 is being revoked to eliminate obsolete guidance 
and reduce industry burdens.

EFFECTIVE DATE: January 4, 1999.
FOR FURTHER INFORMATION CONTACT: Walter W. Morgenstern, Center for 
Devices and Radiological Health (HFZ-305), 2094 Gaither Rd., Rockville, 
MD 20850, 301594-4699, ext. 102.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA issued CPG 7124.28, Reconditioners/Rebuilders of Medical 
Devices, on December 29, 1987. As revised in March 1995, it is 
currently found in Section 300.200 of the Compliance Policy Guides 
Manual. CPG 7124.28 identifies a ``reconditioner/ rebuilder'' as a 
person or firm that acquires ownership of a used device and, for 
purposes of resale or commercial distribution, ``restores'' or 
``refurbishes'' the device to the manufacturer's original or current 
specifications, or new specifications.
    CPG 7124.28 provides that ``reconditioners'' or ``rebuilders'' must 
register under section 510 of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360) and 21 CFR 807.20(a), and they are subject to 
the premarket notification requirements of 21 CFR 807.81. The CPG 
specifies label statements that must be displayed on restored or 
refurbished devices in accordance with 21 CFR 801.1 and, if 
appropriate, 21 CFR 801.109 or 809.10. The CPG also states that 
``reconditioners'' or ``rebuilders'' are subject to biennial inspection 
requirements under the act, if they manufacture class II or class III 
devices, and to the medical device reporting (MDR) requirements in 21 
CFR 803. The CPG further cautions that the resale of devices restored 
by ``reconditioners'' and ``rebuilders'' who do not comply with 
requirements cited in the CPG renders the restored devices adulterated 
under section 501(h) of the act (21 U.S.C. 351(h)), or misbranded under 
sections 502(a) or (f), or 510 of the act (21 U.S.C. 352(a) or (f), or 
360), as appropriate.
    The guidance in CPG 7124.28 represented the agency's current 
thinking, until publication of the CGMP/QS final rule in the Federal 
Register of October 7, 1996 (61 FR

[[Page 67077]]

52602), which codified the QS at 21 CFR 820. The guidance did not 
create or confer any rights for or on any person and did not operate to 
bind FDA or the public. An alternative approach may have been used if 
such approach had satisfied the applicable statute, regulations, or 
both.

II. Basis for Revoking CPG 7124.28

A. Guidance Concerning the Applicability of CGMP Requirements

    CPG 7124.28 applies CGMP requirements to ``reconditioners/
rebuilders'' who ``restore'' or ``refurbish'' used devices. The 
definition that the guidance provides for these entities is now 
considered obsolete and the application of CGMP's in the guidance is 
contrary to current agency thinking, as discussed in section II.A and 
II.B of this document.
    The July 1995 ``Working Draft of the Current Good Manufacturing 
Practice (CGMP) Final Rule'' contained definitions for the terms 
``refurbisher'' and ``servicing.'' It also included ``refurbishers'' 
and ``servicers'' within the definition of ``manufacturer.'' This 
``working draft'' was made available for public comment (60 FR 37856, 
July 15, 1996), and it was discussed extensively in written comments, 
in public and industry testimony, and in recommendations of FDA's GMP 
Advisory Committee during meetings in August and September 1995. 
Comments on the ``working draft'' claimed that using the ``end-of-
life'' characteristic of a device to distinguish a ``refurbisher's'' 
activities from ``servicing'' activities was confusing, unnecessary, 
and raised legal and liability issues (see CGMP/QS final rule (61 FR 
52609, October 7, 1996). The concerns of cost, equity, and competitive 
concerns were also raised regarding the regulation of ``refurbishers,'' 
``servicers,'' and ``third-party'' service organizations (61 FR 52604 
and 52640). Under these concerns, the terms ``refurbisher,'' 
``servicer,'' and ``servicing'' were not included in the final CGMP/QS 
regulation, as they relate to entities outside the control of the 
original device manufacturer, even though FDA believes that ``persons 
who perform such functions meet the definition of manufacturer'' (61 FR 
52610). FDA elected to address the application of CGMP requirements to 
``refurbishers'' and ``servicers'' in a separate rulemaking (61 FR 
52610 and 52611).
    The agency focused, instead, on used-device processors making 
significant modifications to finished devices. The new term 
``remanufacturer'' was added to the final regulation, included within 
the meaning of ``manufacturer,'' and defined in 21 CFR 820.3(w) to mean 
``any person who processes, conditions, renovates, repackages, 
restores, or does any other act to a finished device that significantly 
changes the finished device's performance or safety specifications, or 
intended use.'' As a result of this rulemaking, the guidance in CPG 
7124.28 has become obsolete because its terminology and application of 
CGMP requirements do not conform with the terms and applicability of 
the current CGMP/QS regulation. The CPG applies CGMP requirements to 
``reconditioners'' or ``rebuilders'' who acquire ownership of used 
devices and ``restore'' and/or ``refurbish'' the devices to meet the 
device manufacturer's original or current specifications, or new 
specifications, prior to reselling or remarketing the used devices. The 
only term used in this guidance that is used in the current regulation 
is ``restore.'' By virtue of acquiring ownership of the devices which 
they ``restore'' or ``refurbish,'' the ``reconditioners'' or 
``rebuilders'' identified in CPG 7124.28 would consist almost 
exclusively of entities who operate outside the control of the original 
device manufacturer. As noted previously, the terms ``refurbisher'' and 
``servicer,'' as they relate to such entities, are not found in the 
current regulation and their CGMP responsibilities are to be addressed 
by FDA in a separate rulemaking.
    Thus, the guidance in CPG 7124.28 applies CGMP requirements to 
entities, i.e., ``reconditioners/rebuilders,'' whose definition is 
obsolete and whose definition contains a term, ``refurbishes,'' which 
the agency intends to consider defining in another context. 
Consequently, guidance in CPG 7124.28 applies CGMP's in a manner 
contrary to current agency thinking. For these reasons, then, and in 
conjunction with other used-device remarketing issues discussed in 
section II.B of this document. FDA is revoking rather than revising CPG 
7124.28 in order to eliminate obsolete CGMP guidance, minimize 
confusion, and reduce attendant industry burdens.

B. Guidance Concerning the Applicability of Other Statutory and 
Regulatory Requirements

    CPG 7124.28 applies registration, listing, premarket notification, 
labeling, and MDR reporting requirements to ``reconditioners'' or 
``rebuilders'' of used devices. This portion of the guidance is 
likewise obsolete in applying statutory and regulatory requirements to 
a group of entities whose common definition is no longer considered 
relevant. Such guidance also does not represent current agency 
thinking, as discussed in section II.B of this document.
    On the basis of industry concerns raised during CGMP rulemaking, 
FDA's knowledge of changes in the used-device market, and information 
on used-device ``remarketers'' and ``servicers'' obtained through the 
International Association of Medical Equipment Remarketers, FDA no 
longer believes that the processing, remarketing, or servicing of used 
devices should be characterized in terms of whether or not the 
processor acquires ownership of the device for purposes of resale or 
remarketing. FDA now believes that it may be more appropriate to 
identify and distinguish between the types of processing conducted on 
used devices on the basis of whether or not significant changes occur, 
or are made, in the performance or safety specifications or intended 
use of the finished device, as a result of the processing.
    FDA has already incorporated its current thinking in the definition 
of ``remanufacturer'' that it added to the CGMP/QS regulation. The 
processing activities of a ``remanufacturer'' significantly change the 
safety, performance, or use of a finished device. In the ANPRM 
published in the December 23, 1997, Federal Register (62 FR 67011), FDA 
announced, and solicited public comment upon, its intention to further 
distinguish the used-device market, for regulatory purposes, in terms 
of processors whose activities do not significantly change the 
performance or safety specifications, or intended use of a finished 
device, in contrast to the activities of ``remanufacturers.'' FDA 
preliminarily identified the activities of certain such processors, and 
solicited public comment and input on the tentative definitions it 
drafted and presented in the ANPRM, identifying the activities of 
``refurbishers,'' ``as-is remarketers,'' and ``servicers'' of used 
devices. Public comment was also solicited concerning whether FDA 
should define such processors, or other types of processors identified 
following public comment, through rulemaking or the issuance of 
guidance, under the agency's ``Good Guidance Practices'' (GGP) policy 
(62 FR 8961, February 27, 1997).
    FDA also announced in the December 23, 1997, ANPRM its intention to 
reexamine its options in regulating remarketers and servicers of used 
devices. FDA currently believes that it may be appropriate for the 
agency to apply certain regulatory controls to certain used-device 
processors, using alternative regulatory approaches, if their 
processing activities do not result

[[Page 67078]]

in significant changes in the used device's safety or performance 
specifications, or intended use. Public comment and input were 
solicited concerning alternative regulatory approaches the agency might 
consider in applying regulatory controls upon the activities of 
``refurbishers,'' ``as-is remarketers,'' and ``servicers,'' or other 
types of used-device processors identified following comments. As a 
consequence of these agency actions, the guidance in CPG 7124.28 
concerning the applicability of registration, listing, and other 
statutory and regulatory requirements to ``reconditioners/rebuilders'' 
of used devices is obsolete and no longer represents current agency 
thinking. Pending FDA's issuance of a rule or guidance setting forth 
the agency's current position on these matters, FDA is revoking, rather 
than revising CPG 7124.28 in its entirety in order to eliminate 
obsolete guidance, minimize confusion, and reduce attendant industry 
burdens.

    Dated: October 23, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-32249 Filed 12-3-98; 8:45 am]
BILLING CODE 4160-01-F