[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availability of a draft guidance entitled ``Guidance on the Content and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 This draft guidance is not final nor is it in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 The intent of this draft guidance is to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This draft guidance is posted on the Internet and will be included in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ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance on the Content and Format of Premarket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
