[Federal Register Volume 62, Number 190 (Wednesday, October 1, 1997)]
[Notices]
[Page 51479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25992]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0390 ]


Guidance for the Submission of 510(k)'s for Solid State X-Ray 
Imaging Devices; 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availability of a draft guidance entitled ``Guidance for the Submission 
of 510(k)'s for Solid State X-ray Imaging Devices.'' The draft guidance 
is neither final nor is it in effect at this time. This draft guidance 
applies to a new category of medical devices, Solid State X-ray Imagers 
(SSXI), and is currently available for comment. This draft guidance is 
intended to provide guidance to the significant number of premarket 
(510(k)) submissions resulting from this new technology. The draft 
guidance addresses the type of data needed by the Center for Devices 
and Radiological Health (CDRH) to establish the substantial equivalence 
of an SSXI to a previously cleared conventional radiographic film/
screen system, fluoroscopic image intensified imaging system, or SSXI.

DATES: Written comments by December 30, 1997.
ADDRESSES: Submit written requests for single copies of ``Guidance for 
the Submission of 510(k)'s for Solid State X-ray Imaging Devices'' to 
the Division of Small Manufacturers Assistance (HFZ-200), 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 requests. Submit 
written comments on ``Guidance for the Submission of 510(k)'s for Solid 
State X-ray Imaging Devices'' to the contact person listed below.

FOR FURTHER INFORMATION CONTACT: Robert J. Doyle, Center for Devices 
and Radiological Health (HFZ-476), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-1212.

SUPPLEMENTARY INFORMATION: The final version of this guidance will 
provide instruction concerning the type of data needed by CDRH to clear 
a new category of medical devices, SSXI's, for marketing via section 
510(k) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
360(k)). This new category of medical devices is intended to replace 
conventional x-ray film/screen systems and image intensifier based 
fluoroscopic and image recording systems. As solid state imaging 
technology continues to progress, FDA anticipates a significant number 
of premarket (510(k)) submissions to be based on this new technology. 
By issuing the guidance, FDA hopes to receive a larger percentage of 
complete premarket submissions upon submittal. This will avoid the need 
for additional information requests which are time consuming for both 
FDA and manufacturers.
    Under the Medical Device Amendments to the act, a device may be 
cleared for marketing via a 510(k) premarket notification. To do so, 
the device must be shown to be substantially equivalent to a legally 
marketed predicate device. This guidance sets forth nonclinical and 
clinical data necessary to establish the substantial equivalence of the 
new device to the identified predicate device(s).
    This draft guidance document represents the agency's current 
thinking on the data necessary to establish the substantial equivalence 
of SSXI to a previously cleared device. 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 requirements of the applicable statute, regulations, or both.
    Interested persons may, on or before December 30, 1997, submit to 
the contact person (address above) written comments regarding this 
draft guidance. Persons with access to the Internet may obtain the 
draft guidance via the World Wide Web (WWW) at ``<a href="http://www.fda.gov/
cdrh">http://www.fda.gov/
cdrh</a>''.

    Dated: July 31, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-25992 Filed 9-30-97; 8:45 am]
BILLING CODE 4160-01-F