[Federal Register Volume 63, Number 81 (Tuesday, April 28, 1998)]
[Notices]
[Pages 23292-23293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0238]


Guidance Document for Industry and CDRH Staff for the Preparation 
of Investigational Device Exemptions and Premarket Approval 
Applications for Bone Growth Stimulator Devices; Draft; 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availability of the draft guidance entitled ``Guidance Document for 
Industry and CDRH Staff for the Preparation of Investigational Device 
Exemptions and Premarket Approval Applications for Bone Growth 
Stimulator Devices.'' This guidance is not final or in effect at this 
time. The purpose of this document is to suggest to the device 
manufacturer or investigation sponsor important information which 
should be presented in investigational device exemption (IDE) and 
premarket approval (PMA) applications in order to provide reasonable 
assurance of the safety and effectiveness of these devices for their 
intended uses.

DATES: Written comments concerning this guidance must be submitted by 
July 27, 1998.
ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Guidance Document 
for Industry and CDRH Staff for the Preparation of Investigational 
Device Exemptions and Premarket Approval Applications for Bone Growth 
Stimulator Devices'' to the Division of Small Manufacturers Assistance, 
Center for Devices and Radiological (HFZ-220), 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 document must be submitted to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Comments should be 
identified with the docket number found in brackets in the heading of 
this document. See the Supplementary Information section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: John S. Goode, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2036.

SUPPLEMENTARY INFORMATION:

I. Background

    The preparation of a guidance document for Bone Growth Stimulator 
applications was first initiated by the Division of Surgical and 
Rehabilitation Devices (DSRD) of the Office of Device Evaluation (ODE) 
in conjunction with the Division of Physical Sciences (DPS) and Life 
Sciences (DLS) of the Office of Science and Technology in 1985. The 
purpose of the document was to suggest to the device manufacturer or 
investigation sponsor important information which should be presented 
in IDE and PMA applications in order to provide reasonable assurance of 
the safety and effectiveness of these devices for their intended uses. 
The document went through extensive review by representatives of DSRD, 
DPS, DLS, the Orthopedic and Rehabilitation Devices (ORD) Advisory 
Panel, and industry representatives. Comments and recommendations 
generated by these reviews resulted in a revised draft document, which 
was presented for discussion during an open public session of the ORD 
Advisory Panel meeting held on October 31, 1986. Subsequent to the 
panel meeting, the Health Industry Manufacturers Association organized 
a task force which again reviewed the document and suggested changes to 
the Center for Devices and Radiological Health (CDRH) on February 15, 
1988. As a result, a final guidance document was issued on August 12, 
1988. This revised draft of the guidance document was initiated in 
response to discussions and correspondences with sponsors of bone 
growth stimulator devices and other interested parties, and it provides 
additional guidance detailing the ODE's present perspective on issues 
relating to these devices. The revised draft guidance will be 
considered by the ORD Advisory Panel in a meeting to be held on April 
28, 1998, at 9200 Corporate Blvd., Rockville, MD.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
IDE and PMA applications for Bone Growth Stimulators. 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 copies of the draft guidance document entitled 
``Guidance Document for Industry and CDRH Staff for the Preparation of 
Investigational Device Exemptions and Premarket Approval Applications 
for Bone Growth Stimulator Devices'' 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 (487) followed by the pound sign (#). Then follow the remaining 
voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance document 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

[[Page 23293]]

regular basis, the CDRH home page includes the draft guidance document 
entitled ``Guidance Document for Industry and CDRH Staff for the 
Preparation of Investigational Device Exemptions and Premarket Approval 
Applications for Bone Growth Stimulator Devices,'' 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. The guidance document entitled ``Guidance 
Document for Industry and CDRH Staff for the Preparation of 
Investigational Device Exemptions and Premarket Approval Applications 
for Bone Growth Stimulator Devices'' will be available at <a href="http://
www.fda.gov/cdrh/draftgui.html">http://
www.fda.gov/cdrh/draftgui.html</a>.
    A text-only version of the CDRH Web site is also available from a 
computer or VT-100 compatible terminal by dialing 800-222-0185 
(terminal settings are 8/1/N). Once the modem answers, press Enter 
several times and then select menu choice 1: FDA BULLETIN BOARD 
SERVICE. From there follow instructions for logging in, and at the BBS 
TOPICS PAGE, arrow down to the FDA home page (do not select the first 
CDRH entry). Then select Medical Devices and Radiological Health. From 
there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general 
information, or arrow down for specific topics.

IV. Comments

    Interested persons may, on or before July 27, 1998, 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: April 22, 1998.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-11158 Filed 4-27-98; 8:45 am]
BILLING CODE 4160-01-F