[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
[Notices]
[Pages 59794-59795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29565]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0729]


Draft ``Guidance on the Content and Format of Premarket 
Notification [510(k)] Submissions of Washers and Washer-Disinfectors;'' 
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availability of a draft guidance entitled ``Guidance on the Content and 
Format of Premarket Notification [510(k)] Submissions of Washers and 
Washer-Disinfectors.'' This draft guidance is not final nor is it in 
effect at this time. FDA recognizes the importance of providing 
applicants and other interested parties the agency's 510(k) submission 
criteria for washers and washer-disinfectors intended to process 
reusable medical devices. The intent of this draft guidance is to 
provide specific directions regarding information and data which should 
be submitted to FDA in 510(k) submission for these types of devices. 
This draft guidance is posted on the Internet and will be included in 
the panel package for the formal classification of these devices at the 
General Hospital and Personal Use Devices Panel meeting on September 
14, 1998.

DATES: Written comments concerning this guidance must be received by 
February 3, 1999.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance on the Content and Format of Premarket 
Notification [510(k)] Submissions of Washers and Washer-Disinfectors'' 
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. Written comments concerning this guidance must 
be submitted 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 written comments on ``Guidance 
on the Content and Format of Premarket Notification [510(k)] 
Submissions of Washers and Washer-Disinfectors'' to the contact person 
listed below. See the Supplementary Information section for information 
on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Chiu S. 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

    Washers and washer-disinfectors intended for cleaning and 
disinfection of reusable medical devices, such as stainless steel 
devices, surgical instruments, including devices with lumens, 
respiratory therapy equipment, and other medical devices, were legally 
marketed devices prior to the enactment of the Medical Device 
Amendments of 1976. These devices are considered ``unclassified'' 
medical devices. On June 2, 1998, FDA published on the Internet a 
guidance document entitled ``CDRH Guidance Document for Washers and 
Washer-Disinfectors Intended for Processing Reusable Medical Devices'' 
to provide direction to the regulated industry on when a premarket 
notification [510(k)] submission is required for these unclassified 
washers and washer-disinfectors. In the ``CDRH Guidance Document for 
Washers and Washer-Disinfectors Intended for Processing Reusable 
Medical Devices,'' the agency made the commitment to provide industry 
with guidance on the information and data which should be included in a 
510(k) submission. This draft guidance entitled ``Guidance on the 
Content and Format of Premarket Notification [510(k)] Submissions of 
Washers and Washer-Disinfectors'' provides regulated industry with 
specific guidance on the information and data that should be included 
in a 510(k) submission for these devices.
    These unclassified washers and washer-disinfectors will undergo 
formal classification at the September 14, 1998, General Hospital and 
Personal Use Devices Panel meeting.

II. Significance of Guidance

    This draft guidance represents the agency's current thinking on the

[[Page 59795]]

information and data which should be included in a 510(k) submission 
for the washers and washer-disinfectors intended to process reusable 
medical devices. 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 ``Guidance on the Content and Format of 
Premarket Notification [510(k)] Submissions of Washers and Washer-
Disinfectors'' 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 1252 
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 World Wide Web (WWW). CDRH maintains an entry on the WWW 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with access to the Web. 
Updated on a regular basis, the CDRH home page includes ``Guidance on 
the Content and Format of Premarket Notification [510(k)] Submissions 
of Washers and Washer-Disinfectors,'' 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 on the Content and Format of Premarket 
Notification [510(k)] Submissions of Washers and Washer-Disinfectors'' 
will be available at ``http://www.fda.gov/cdrh/ode/Edxdn.HTML''.

IV. Comments

    Interested persons may, on or before February 3, 1999, submit to 
Dockets Management Branch (address above) written comments regarding 
this draft 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 draft guidance and received comments may be seen in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: September 8, 1998.
 D.B. Burlington,
 Director, Center for Devices and Radiological Health.
[FR Doc. 98-29565 Filed 11-4-98; 8:45 am]
BILLING CODE 4160-01-F