[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availability of the draft guidance entitled ``Guidance Document for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diskette of the draft guidance document entitled ``Guidance Document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 http://
www.fda.gov/cdrh/draftgui.html.
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