[Federal Register Volume 64, Number 25 (Monday, February 8, 1999)]
[Notices]
[Pages 6100-6101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-1165]


Draft Guidance for the Content of Premarket Notifications 
(510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for 
the Fragmentation of Kidney and Ureteral Calculi; 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availability of the draft guidance entitled ``Guidance for the Content 
of

[[Page 6101]]

Premarket Notifications (510(k)s) for Extracorporeal Shock Wave 
Lithotripters Indicated for the Fragmentation of Kidney and Ureteral 
Calculi.'' This guidance is neither final nor is it in effect at this 
time. This draft guidance describes the types of information that 
should be submitted in a premarket notification to support a decision 
of substantial equivalence for an extracorporeal shock wave 
lithotripter indicated for the fragmentation of kidney and ureteral 
calculi, including potential special controls. Although renal and 
ureteral extracorporeal shock wave lithotripters are currently 
classified into class III (premarket approval), elsewhere in this issue 
of the Federal Register, FDA is publishing a proposed rule to 
reclassify these devices to class II (special controls). It is 
anticipated that this draft guidance will become effective if/when a 
final rule regarding this reclassification has been issued.

DATES: Written comments concerning this draft guidance must be received 
by May 10, 1999.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance. Submit written requests for 
single copies on a 3.5'' diskette of the draft guidance document 
entitled ``Guidance for the Content of Premarket Notifications 
(510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the 
Fragmentation of Kidney and Ureteral Calculi'' 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 draft guidance must be submitted 
to the Dockets Management Branch, (HFA-305), Food and Drug 
Administration, rm. 1061, 5630 Fishers Lane, Rockville, MD 20852. 
Comments should be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: John H. Baxley, Center for Devices and 
Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2194.

SUPPLEMENTARY INFORMATION:

I. Background

     Extracorporeal shock wave lithotripters for the fragmentation of 
kidney and ureteral calculi are currently postamendments class III 
devices, requiring either an approved premarket approval (PMA) 
application or declared complete product development protocol (PDP) 
prior to commercial distribution in the United States. Elsewhere in 
this issue of the Federal Register, FDA is publishing a proposed rule 
to reclassify extracorporeal shock wave lithotripters from class III 
into class II (special controls). To facilitate the proposed 
reclassification, FDA has prepared the draft guidance entitled 
``Guidance for the Content of Premarket Notifications (510(k)s) for 
Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation 
of Kidney and Ureteral Calculi.'' This draft guidance describes the 
special controls that FDA is including in the proposed rule, and it 
also provides general guidance to industry on the content of premarket 
notifications for these devices.
     A meeting of the Gastroenterology and Urology Devices Advisory 
Panel of the Medical Devices Advisory Committee was held on July 30, 
1998, to seek its recommendations on this proposed reclassification, 
including advice on special controls and the content of premarket 
notifications. The panel unanimously voted to reclassify the 
extracorporeal shock wave lithotripter for the fragmentation of renal 
and ureteral stones into class II. Comments from the panel have been 
incorporated into this draft guidance document.

II. Significance of Guidance

     This draft guidance document represents the agency's current 
thinking on the reclassification of extracorporeal shock wave 
lithotripters indicated for the fragmentation of kidney and ureteral 
calculi. 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 draft guidance document is issued as a Level 1 guidance 
consistent with GGP's.

III. Electronic Access

     In order to receive ``Guidance for the Content of Premarket 
Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters 
Indicated for the Fragmentation of Kidney and Ureteral Calculi'' 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 (1226) followed by the pound sign 
(#). Then follow the remaining voice prompts to complete your request.
     Persons interested in obtaining a copy of the draft 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 
WWW. Updated on a regular basis, the CDRH home page includes ``Guidance 
for the Content of Premarket Notifications (510(k)s) for Extracorporeal 
Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and 
Ureteral Calculi,'' 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.

IV. Comments

     Interested persons may, on or before May 10, 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 guidance document and received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: January 21, 1999.
Linda S. Kahn,
Deputy Director for Regulations Policy,
Center for Devices and Radiological Health.
[FR Doc. 99-2690 Filed 2-5-99; 8:45 am]
BILLING CODE 4160-01-F