[Federal Register Volume 67, Number 26 (Thursday, February 7, 2002)]
[Notices]
[Pages 5833-5834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3020]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0729]


Medical Devices; Class II Special Controls Guidance Document: 
Medical Washers and Medical Washer-Disinfectors; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revision to the draft guidance entitled ``Guidance on 
the Content and Format of Premarket Notification (510(k)) Submission of 
Washers and Washer-Disinfectors.'' (63 FR 59794). The revised guidance 
renamed ``Class II Special Controls Guidance Document: Medical Washers 
and Medical Washer-Disinfectors'' will serve as a special control for 
medical washers and medical washer-disinfectors if they are classified 
into class II. Elsewhere in this issue of the Federal Register, FDA is 
issuing a proposed rule to classify medical washers as class II 
(special controls).

DATES: Submit written or electronic comments at any time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Class II Special Controls 
Guidance Document: Medical Washers and Medical Washer-Disinfectors'' to 
the Division of Small Manufacturers, International and Consumer 
Assistance (HFZ-220), Center for Devices and Radiological Health 
(CDRH), 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. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments 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. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Chiu Lin, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8913.

SUPPLEMENTARY INFORMATION:

I. Background

    The intent of this guidance document for class II medical washers 
and medical washer-disinfectors is: (1) To provide applicants specific 
directions regarding information and data that should be submitted to 
FDA in a 510(k) submission for medical washer-disinfectors intended to 
clean and provide high level disinfection, and (2) to provide 
recommendations on information and data to be held as part of the 
design control record for a medical washer intended to clean medical 
devices or a medical washer-disinfector intended to clean and provide 
either a low or intermediate level of disinfection for medical devices. 
The General Hospital and Personal Use Devices Advisory Panel met on 
September 14, 1998, and unanimously recommended that the medical washer 
and washer-disinfector be classified into class II.
    FDA made the draft guidance entitled ``Guidance on the Content and 
Format of Premarket Notification (510(k)) Submissions of Washers and 
Washer-Disinfectors'' available for comment on November 5, 1998 (63 FR 
59794). The public comment period closed February 3, 1999. FDA reviewed 
the comments and revised the draft guidance as appropriate. The final 
guidance renamed ``Class II Special Controls Guidance Document: Medical 
Washers and Medical Washer-Disinfectors'' replaces the November 5, 
1998, draft.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
medical washers and medical washer-disinfectors. 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 and regulations.
    The agency has adopted good guidance practices (GGPs), and 
published the final rule, which set forth the agency's regulations for 
the development, issuance, and use of guidance documents (21 CFR 
10.115). This guidance document is issued as level 1 guidance in 
accordance with the GGP regulations.

III. Electronic Access

    In order to receive ``Class II Special Controls Guidance Document: 
Medical Washers and Medical Washer-Disinfectors'' via your fax machine, 
call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 
from a touch-tone telephone. Press 1 to enter

[[Page 5834]]

the system. At the second voice prompt press 1 to order a document. 
Enter the document number 1252 followed by the pound sign (#). 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 Internet access. Updated on a 
regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, 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. Guidance documents are also available on the Dockets Management 
Branch Web site at http://www.fda.gov/ohrms/dockets/default.htm.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding this guidance 
at any time. Submit two copies of any comments, 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 may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 24, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-3020 Filed 2-6-02; 8:45 am]
BILLING CODE 4160-01-S