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

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

[[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