[Federal Register Volume 65, Number 29 (Friday, February 11, 2000)]
[Notices]
[Pages 7027-7029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3345]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0053]


Reprocessing and Reuse of Single-Use Devices: Review 
Prioritization Scheme; and 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availability of two draft guidance documents entitled ``Reprocessing 
and Reuse of Single-Use Devices: Review Prioritization Scheme;'' and 
``Enforcement Priorities for Single-Use Devices Reprocessed by Third 
Parties and Hospitals.'' These draft guidance documents are neither 
final, nor are they in effect at this time. The review prioritization 
scheme guidance document sets forth factors FDA (we) would consider in 
categorizing a reprocessed single-use device (SUD) as high, moderate, 
or low risk. The enforcement priorities guidance document sets forth 
our priorities for various requirements based on the risk 
categorization of a device.

DATES: Submit written comments concerning either guidance by April 11, 
2000.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance. Submit written requests for single 
copies (on a 3.5 diskette) of the guidance documents entitled 
``Reprocessing and Reuse of Single-Use Devices: Review Prioritization 
Scheme'' and ``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

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your request to 301-443-8818. Submit written comments concerning these 
guidances 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.

FOR FURTHER INFORMATION CONTACT: Regarding ``Reprocessing and Reuse Of 
Single-Use Devices: Review Prioritization Scheme,'' Barbara C. 
Zimmerman, Center for Devices and Radiological Health (HFZ-450), Food 
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 
301-443-8517.
    Regarding ``Enforcement Priorities For Single-Use Devices 
Reprocessed by Third Parties and Hospitals,'' Larry D. Spears, Center 
for Devices and Radiological Health (HFZ-340), Food and Drug 
Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4646.

SUPPLEMENTARY INFORMATION:

I. Background

    The practice of reprocessing devices that are intended for single-
use (SUD's) began in hospitals in the late 1970's. Since that time, the 
practice has become widespread. We have not regulated original 
equipment manufacturers (OEM's), third parties, and hospitals that 
engage in reprocessing SUD's in the same manner. In particular, to 
date, we have enforced existing premarket submission requirements only 
against OEM's.
    In response to concerns raised by original equipment manufacturers 
and consumers about safety issues associated with reprocessing SUD's, 
in the Federal Register of November 3, 1999 (64 FR 59782), we announced 
a proposed strategy on reuse of SUD's. The essence of this proposed 
strategy was to regulate OEM's, third parties, and hospitals that 
reprocess SUD's in the same manner.
    On December 14, 1999, we held a public meeting to provide the 
opportunity to interested parties to comment on its proposed strategy. 
We received comments on the proposed strategy from OEM's, third party 
reprocessors, health-care professionals, and other interested parties, 
both during and subsequent to this meeting.
    One of the principle components of our proposed strategy was the 
establishment of agency enforcement priorities concerning regulatory 
requirements for third party and hospital reprocessors of SUD's. We 
proposed to prioritize its enforcement activities based on the degree 
of risk posed by the reprocessing. To accomplish this process, we 
proposed the following steps:
    (1) Develop a list of commonly reused SUD's;
    (2) Develop a list of factors to determine the degree of risks 
associated with reprocessing devices;
    (3) Use that list of factors to divide the list of commonly 
reprocessed SUD's into three categories of risk--high, moderate, and 
low; and
    (4) Develop priorities for enforcement of regulatory requirements 
for hospitals and third party reprocessors, based on the category of 
risk (high, moderate, and low).
    We received many comments expressing concern that we were proposing 
to develop a new regulatory system for reprocessed SUD's that was 
outside of the current classification system under section 513 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c) for class I, II, 
and III devices. We clarified at the meeting that the categorization of 
devices by risk would be used solely in setting enforcement priorities; 
it would not entail a process outside of the current classification 
system.
    Under the proposed strategy, devices would still be classified as 
class I, II, and III and still have premarket notification (510(k)) or 
premarket approval (PMA) requirements based on that classification. The 
proposed prioritization scheme would only apply to our enforcement 
priorities, it would not relate to established premarket submission 
requirements. For example, if we categorized a certain type of device 
as high risk under the prioritization scheme, it would mean that we 
would set the enforcement of regulatory requirements for that device as 
the highest priority. It would not affect the classification of the 
device or the type of marketing submission that would be required for 
that device. If the generic type of that device were class III, we 
would generally require an approved PMA application before marketing. 
If the generic type of device were class II, we would require clearance 
of a 510(k) before marketing. A high risk categorization, therefore, 
would affect the timing of our enforcement of these requirements rather 
than the requirements themselves.
    We are issuing two companion draft guidance documents that would 
implement our proposed enforcement strategy:
    (1) One draft guidance is entitled ``Reprocessing and Reuse of 
Single-Use Devices: Review Prioritization Scheme.'' This draft guidance 
sets forth factors we would consider in categorizing a reprocessed 
device as high, moderate, or low risk, which we would use in setting 
our enforcement priorities. An appendix to the guidance lists commonly 
reprocessed SUD's, and lists what category of risk we believe a 
particular device falls within if reprocessed.
    On December 9, 1999, we published an earlier version of the 
guidance document on our Internet site. The Federal Register document 
announcing this earlier draft guidance version was published on 
February 2, 2000 (65 FR 4985).
    The revised draft guidance document incorporates comments we 
received at the December 14, 1999, public meeting and written 
submissions, and includes the risk category that we believe a 
particular device falls within if reprocessed. This revised guidance 
replaces the earlier version, however, it is a draft guidance that is 
not in effect at this time.
    (2) The other draft guidance document is entitled ``Enforcement 
Priorities for Single-Use Devices Reprocessed by Third Parties and 
Hospitals.'' This draft guidance document sets forth our priorities for 
enforcing various regulatory requirements, based on the categorization 
of a device, as described in the risk categorization guidance.

II. Significance of Guidance

    These guidance documents represent the agency's current thinking on 
the factors we would consider in categorizing a reprocessed device as 
high, moderate, or low risk. They also identify how commonly 
reprocessed devices might be categorized and how this categorization 
affects the agency's regulatory priorities.
    These guidance documents do not create or confer any rights for or 
on any person and do not operate to bind us or the public.
    The agency has adopted Good Guidance Practices (GGP's), which set 
forth our policies and procedures for the development, issuance, and 
use of guidance documents (62 FR 8961, February 27, 1997). These 
guidance documents are issued as Level 1 guidance consistent with 
GGP's.

III. Electronic Access

    In order to receive these draft guidance documents via your fax 
machine, call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 
301-827-0111 from a touch-tone telephone. At the first voice prompt 
press 1 to access DSMA Facts, at second voice prompt press 2, and then 
enter the document number (1156- Reprocessing

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and Reuse of Single-Use Devices: Review Prioritization Scheme) or 
(1029-Enforcement Priorities for Single-Use Devices Reprocessed by 
Third Parties and Hospitals) followed by the pound sign (#). Then 
follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of these guidance documents 
may do so by 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 the 
guidance documents entitled ``Reprocessing and Reuse of Single-Use 
Devices: Review Prioritization Scheme'' and ``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. ``Reprocessing and Reuse of 
Single-Use Devices: Review Prioritization Scheme'' will be available at 
http://www.fda.gov/cdrh/ODE. ``Enforcement Priorities for Single-Use 
Devices Reprocessed by Third Parties and Hospitals'' will be available 
at http://www.fda.gov/cdrh/OC.

IV. Comments

    Interested persons may submit to Dockets Management Branch (address 
above) written comments regarding these draft guidance documents by 
April 11, 2000. 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 documents and received comments may be seen in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: February 8, 2000,
Margaret Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-3345 Filed 2-9-00; 12:28 pm]
BILLING CODE 4160-01-F