[Federal Register Volume 62, Number 114 (Friday, June 13, 1997)]
[Notices]
[Pages 32351-32352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15452]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0209]


Information for Manufacturers Seeking Marketing Clearance of 
Diagnostic Ultrasound Systems and Transducers; Draft Guidance; 
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availability of a draft guidance document entitled, ``Information for 
Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound 
Systems and Transducers.'' This draft guidance is intended to assist 
the manufacturer in preparing a complete 510(k) premarket notification 
submission to the Center for Devices and Radiological Health (CDRH) or 
a third party reviewing organization. The agency is seeking public 
comment on the draft guidance.

DATES: Written comments on the draft guidance document may be submitted 
by July 28, 1997.

ADDRESSES: Submit written comments and requests for single copies of 
the draft guidance document to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Robert A. Phillips, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20852, 301-594-1212.
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is making this draft guidance document available in order to 
assist manufacturers preparing notification submissions for diagnostic 
ultrasound systems and transducers. In addition to basic information on 
submitting a 5l0(k) for these devices, the draft guidance contains 
specific information on device description, predicate device 
comparison, acoustic output reporting, general clinical safety and 
effectiveness, and labeling. The draft guidance also contains 
information on submitting a post-clearance special report called the 
``510(k) special report'' providing production acoustic output values 
and other information.
    A guidance document does not bind FDA or the public, and it does 
not create or confer any rights, privileges, or benefits for or on any 
person, however, it does represent the agency's current thinking on the 
subjects discussed therein. The draft guidance document announced in 
this notice represents the agency's tentative thinking of the subjects 
discussed therein.

II. Request for Comments

    Interested persons may, on or before July 28, 1997, submit to the 
Dockets Management Branch (address above) written comments on the draft 
guidance document. 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. Received comments may be seen in the office

[[Page 32352]]

above between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    An electronic version of this draft guidance also is available via 
Internet using the World Wide Web (WWW) (connect to cdrh home page at 
http://www.fda.gov/cdrh/ode/usgudode.pdf).

    Dated: June 4, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-15452 Filed 6-12-97; 8:45 am]
BILLING CODE 4160-01-F