[Federal Register Volume 65, Number 157 (Monday, August 14, 2000)]
[Notices]
[Pages 49583-49585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20462]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0053]


Guidance for Industry on Enforcement Priorities for Single-Use 
Devices Reprocessed by Third Parties and Hospitals; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance document entitled ``Enforcement Priorities 
for Single-Use Devices Reprocessed by Third Parties and Hospitals.'' 
This guidance document finalizes the agency's policy on how it intends 
to regulate third parties and hospitals engaged in reprocessing single-
use devices (SUD's) for reuse. This guidance document sets forth FDA's 
priorities for premarket submission requirements, which will be based 
on the device's Code of Federal Regulations (CFR) classification (i.e., 
class I, II, and III).

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the guidance document entitled ``Enforcement Priorities for Single-
Use Devices Reprocessed by Third Parties and Hospitals'' to the 
Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 301-443-8818. Submit written comments concerning this 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Comments should be identified with the docket number found in brackets 
in the heading of this document. See the Supplementary Information 
section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Larry D. Spears, Center for Devices 
and Radiological Health (HFZ-340), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-4646.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 3, 1999 (64 FR 59782), FDA 
published a proposed strategy on the reuse of SUD's. This proposal 
identified the steps under consideration in the development of the 
agency's SUD reprocessing policy. These steps were to: (1) Develop a 
list of commonly reused SUD's; (2) develop a list of factors to 
determine the degree of risk associated with reprocessing devices; (3) 
apply those factors to the list of commonly reprocessed SUD's and 
categorize them into three categories (high, moderate, and low); and 
(4) develop priorities for enforcement of premarket submission 
regulatory requirements for third party and hospital reprocessors, 
based on the category of risk.
    In addition to publishing the proposed strategy document for public 
comment, FDA also sponsored a teleconference on November 10, 1999, and 
convened an open public meeting on December 14, 1999 (64 FR 63818,

[[Page 49584]]

November 22, 1999), to obtain comments on the proposed strategy. As a 
result of the comments received, FDA published on February 11, 2000 (65 
FR 7027), two companion draft guidances entitled ``Reprocessing and 
Reuse of Single-Use Devices: Review Prioritization Scheme'' and 
``Enforcement Priorities for Single-Use Devices Reprocessed by Third 
Parties and Hospitals.''
    The draft guidance entitled ``Reprocessing and Reuse of Single-Use 
Devices: Review Prioritization Scheme'' (the ``RPS guidance'') set 
forth factors that the agency would consider in categorizing the risk 
associated with SUD's that are reprocessed. This process, called the 
Risk Prioritization Scheme, would determine the risk categories for 
frequently reprocessed SUD's by assigning an overall risk to each SUD 
based on the risk of infection and the risk of inadequate performance 
following reprocessing. The three categories of risk were high, 
moderate, and low. The risk category would then be used to set FDA's 
enforcement priorities for premarket submission requirements. Appendix 
2 of the RPS guidance included a list of frequently reprocessed SUD's 
and their risk category according to the Risk Prioritization Scheme. 
Under this proposed guidance document, FDA would consider any 
reprocessed SUD that was not included on the list to be high risk.
    The draft guidance entitled ``Enforcement Priorities for Single-Use 
Devices Reprocessed by Third Parties and Hospitals'' (the ``SUD 
enforcement guidance'') set forth FDA's priorities for enforcing 
premarket submission requirements for premarket notifications 
(510(k)'s) or for premarket approval applications based on the risk 
categorization of a device as determined by the companion RPS guidance. 
Premarket submission requirements for SUD's deemed high risk by the 
Risk Prioritization Scheme would be implemented within 6 months of the 
issuance of FDA's final guidance document on reuse; within 12 months 
for moderate risk SUD's; and within 18 months for low risk SUD's. FDA 
would actively enforce nonpremarket requirements within 6 months of 
issuance of FDA's final reuse guidance document. FDA received over 150 
written comments to the docket on the November 1999 proposed strategy 
plan and to the February 2000 draft guidances.
    FDA received many comments that supported the agency's decision to 
actively regulate third party and hospital reprocessors and its 
decision to exclude ``opened-but-unused'' SUD's from this enforcement 
strategy. FDA also learned that stakeholders and interested parties 
believed that the Risk Prioritization Scheme lacked clarity and was too 
subjective. To demonstrate this point, several stakeholders used the 
scheme to evaluate their products. In all cases the stakeholders' risk 
category for their devices ranked higher or lower than FDA's risk 
category for the same devices. Several commentors expressed concern 
that FDA was imposing burdensome regulations on hospitals. Others were 
concerned that many hospitals are not prepared to comply with the 
agency's premarket submission requirements due to their lack of 
experience in this area or to their limited financial resources. 
Several stakeholders identified additional SUD's that they were 
currently reprocessing or were considering reprocessing in the future 
that were not on FDA's current list of frequently reprocessed SUD's.
    As a result of the comments the agency received, FDA has revised 
the final SUD regulatory strategy as follows:
    1. The proposed Risk Prioritization Scheme will not be used to 
determine the timing of FDA's enforcement priorities for the premarket 
submission requirements. Rather, FDA will use the device classification 
listed in the CFR (i.e., class I, class II, or class III) to set its 
enforcement priorities for the premarket submission requirements.
    2. FDA intends to enforce premarket submission requirements within 
6 months of issuance of the final SUD enforcement guidance document for 
all class III devices, within 12 months for class II devices, and 18 
months for class I devices. At a later date, FDA intends to examine, on 
a case-by-case basis, the need to revoke exemptions from premarket 
requirements for class I and II exempt products based upon the risks 
that may exist due to reprocessing.
    3. For hospital reprocessors, FDA intends to establish a 1-year 
phase in for active enforcement of the Federal Food, Drug, and Cosmetic 
Act's (the act's) nonpremarket requirements (e.g., registration, 
listing, medical device reporting, tracking, corrections and removals, 
quality system, and labeling). The agency will use the 1-year period 
following issuance of this final guidance document to educate hospitals 
about their regulatory obligations. FDA does not anticipate that the 1-
year extension of enforcement discretion following issuance of this 
guidance document will pose any significant public health risks because 
the agency has no evidence at this time to demonstrate that 
reprocessing and reuse of SUD's is posing any imminent danger to public 
health.
    4. The ``List of Frequently Reprocessed SUD's'' has been expanded 
to include additional SUD's that are currently being reprocessed. As 
noted previously, FDA will use the device classification listed in the 
CFR to set its enforcement priorities for the premarket submission 
requirements for all devices. The regulatory premarket submission 
requirements for reprocessed SUD's that are not included on this list 
will be based on the device's CFR classification (e.g., class I, II, or 
III).
    As stated in FDA's November 3, 1999, proposed strategy plan on the 
reuse of SUD's, FDA's primary goal is to ensure a reprocessing and 
reuse regulatory program based on good science that protects public 
health, while ensuring that the regulatory requirements are equitable 
to all parties. FDA does not believe that the changes to its final SUD 
regulatory strategy pose any significant public health risks. Rather, 
the agency believes that these changes may facilitate the 
implementation of the reuse policy by eliminating confusion or 
misunderstanding regarding a device's risk category and the timing of 
premarket submissions.
    The major change in FDA's plan is the agency's conclusion that it 
should rely on the traditional device classification scheme rather than 
the draft Risk Prioritization Scheme to establish its enforcement 
priorities for the premarket submission requirements. FDA was concerned 
by comments that stakeholders' interpretation of the Risk 
Prioritization Scheme resulted in significant differences between the 
risk category assigned to an SUD by FDA and by the stakeholders. 
Subjective differences interpreting the Risk Prioritization Scheme 
could cause some SUD reprocessors to believe that their devices are a 
lower risk category than FDA's assessment. The agency concluded that 
disagreements over FDA's risk category for an SUD could cause undue 
delays in reprocessors complying with the act's premarket submission 
requirements. The existing CFR device classification system, on the 
other hand, is an established categorization system that is familiar to 
all device manufacturers and many device users. Using the CFR device 
classification system should eliminate problems with the proposed Risk 
Prioritization Scheme identified by stakeholders.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
the regulation of third parties and hospitals

[[Page 49585]]

engaged in the reprocessing of SUD's. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the applicable statute, regulations, or both.
    The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance document is issued as a Level 1 guidance 
consistent with GGP's.

III. Electronic Access

    In order to receive ``Enforcement Priorities for Single-Use Devices 
Reprocessed by Third Parties and Hospitals'' via your fax machine, call 
the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a 
touchtone telephone. At the first voice prompt press 1 to access DSMA 
Facts, at the second voice prompt press 2, and then enter the document 
number (1168) followed by the pound sign (#). Then follow the remaining 
voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. CDRH maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with access to the Internet. Updated 
on a regular basis, the CDRH home page includes ``Enforcement 
Priorities for Single-Use Devices Reprocessed by Third Parties and 
Hospitals,'' device safety alerts, Federal Register reprints, 
information on premarket submissions (including lists of approved 
applications and manufacturers' addresses), small manufacturers' 
assistance, information on video conferencing and electronic 
submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. ``Enforcement Priorities for Single-Use Devices Reprocessed by 
Third Parties and Hospitals'' is also available at http://www.fda.gov/cdrh/comp/guidance/1168.pdf.

IV. Comments

    Interested persons may, at any time, submit written comments 
regarding this guidance to the Dockets Management Branch (address 
above). Such comments will be considered when determining whether to 
amend the current guidance. 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. The guidance document and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 31, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-20462 Filed 8-11-00; 8:45 am]
BILLING CODE 4160-01-F