[Federal Register Volume 63, Number 233 (Friday, December 4, 1998)]
[Notices]
[Pages 67076-67078]
From the Federal Register Online via the Government Publishing 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