[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Diagnostic Ultrasound Systems and Transducers; Draft Guidance;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availability of a draft guidance document entitled, ``Information for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 This draft guidance is intended to assist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comment on the draft guidance.
DATES: Written comments on the draft guidance document may be submitted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the draft guidance document to the Dockets Management Branch (HFA-305),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access to the draft guidance.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FDA is making this draft guidance document available in order to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submitting a 5l0(k) for these devices, the draft guidance contains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 The draft guidance also contains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
